Healthy MenPhase 1CCN005BNCT02994602
Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males
A Phase 1 study testing Nestorone + Testosterone Combination Gel in people with Healthy Men and Male Contraception, run by Kimberly Myer at 2 sites in United States.
Trial summary
This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Men, Male Contraception, Healthy Women
- What is being tested?
- Nestorone + Testosterone Combination Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2017to Oct 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men who meet all the following criteria will be eligible for enrollment in the trial:
- Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;
- 18 to 50 years of age;
- BMI ≥ 18 and < 35 kg/m2;
- No history of androgen use prior to the first screening visit as follows:
- 1 month prior for oral or transdermal androgen,
Show all 19Show fewer
- 3 months prior for Testosterone cypionate or enanthate injection,
- 6 months prior for Testosterone undecanoate injection;
- Agreement to use a recognized effective method of short acting contraception with his partner (i.e. at a minimum use double-barrier method such as a condom with spermicide) during the entire study;
- In the opinion of the investigator, male subject is willing and able to comply with the protocol;
- Provision of valid, written and informed consent.
- Female participant - Inclusion Criteria
- Women who meet all the following criteria will be eligible for enrollment in the trial:
- Good general health (BMI ≥18 and <30 kg/m2)with no chronic medical conditions that result in periodic exacerbations which require significant medical care;
- Aged between 18 and 40 years, at the enrollment visit;
- Not pregnant and not breastfeeding.
- Agreement to use a recognized effective method of contraception throughout the study
- Willingness and ability to provide valid, written and informed consent and to comply with the protocol;
- No desire for pregnancy within the next 6 months.
Who cannot join
- Men who meet any of the following criteria are not eligible for enrollment in the trial:
- Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
- Men not living in the catchment area of the study site or within a reasonable travel time from the site.
- Any clinically significant abnormal findings at screening per the Investigator's medical judgement.
- Elevated PSA (e.g. levels ≥ 4 ng/mL), according to study site's local laboratory reference normal values for adult men.
- Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction. Other abnormal laboratory values may also be exclusionary, if so considered by the investigator to be clinically significant.
Show all 37Show fewer
- Use of androgens or other anabolic steroids that may affect testosterone measurements
- Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 3 measurements will be considered).
- History of hypertension (well-controlled treated hypertension (< 135/85) is allowed).
- Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
- Known hypersensitivity to progestins or testosterone.
- History of prostate or breast carcinoma
- Significant lower urinary obstructive symptoms (IPSS > 19).
- Known history of significant cardiac, renal, hepatic or prostatic disease.
- History of thromboembolic disease.
- A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV, or morbid obesity.
- Current active or ongoing Hepatitis infection
- Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
- Known active or chronic dermatitis or other severe skin disorder.
- Desiring fertility within 6 months of study participation.
- History of severe depression or other serious mental health disorder.
- Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their sporting status.
- Female participant - Exclusion Criteria
- Women who meet any of the following criteria are not eligible for enrollment in the trial:
- Desire to become pregnant during the study.
- Breastfeeding
- Known or suspected current alcoholism or drug abuse.
- History of thrombosis
- Serum testosterone outside normal reference ranges by local laboratory standards or evidence of hirsutism (modified Ferriman-Galwey score > 8)
- Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
- Current pregnancy.
- Known hypersensitivity to progestins or testosterone.
- Any clinically significant abnormal findings at screening per the Investigator's medical judgement.
- Use of androgens or other anabolic steroids that may affect testosterone measurements.
- Known active or chronic dermatitis or other severe skin disorder.
- Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
- Not living in the catchment area of the study site or within a reasonable travel time from the site.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Washington Medical Center & Health Sciences
Seattle, Washington, 98195
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: An Open-Label Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males: Effect of Washing or Clothing Barrier to the Application
This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.
Read the detailed description
This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15.
On day 1, the male participant will wear a 100% cotton T-shirt over the application area before skin contact with the female.
On day 8, the male participant will shower approximately 1 hour and 45 minutes after gel application and engage in skin contact with the female participant (2 hours after gel application) after washing the area with soap and water then drying it. A measurement of residual Nestorone and testosterone will be taken from the male's skin on a single location of the application site using adhesive D-square strips 90 minutes after application (30 minutes before shower/90 minutes after gel application) and 30 minutes after the shower and rubbing (150 minutes after application).
On day 15, there will be no shower or clothing barrier for the male participant before skin contact with the female participant. A measurement of residual Nestorone and testosterone will be taken from a single location of the application using adhesive D-square strips site 90 minutes and 150 minutes after the application.
An end of study/exit visit will occur for both male and female participants two weeks after treatment completion.
- Conditions
- Healthy Men, Male Contraception, Healthy Women, Product Transference
- Being tested
- Nestorone + Testosterone Combination Gel
- Keywords
- Healthy Men, Male Contraception, Healthy Women, Transfer, Transference, Gel, Nestorone, Testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestorone + Testosterone Combination GelDrug
Also called NES/T gel, NES8/T60
The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
| Study group | Role | What they receive |
|---|---|---|
| Nestorone (NES) + testosterone (T) combined gel | Experimental | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Receives: Drug: Nestorone + Testosterone Combination Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Measured: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Measured: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Measured: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Measured: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Measured: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Measured: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Secondary outcomes (12)
PK of T in Males After NES/T With a T-shirt and After Washing
PK of testosterone in males after wearing a T shirt and after washing will be compared to serum testosterone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration)
Measured: Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
PK of NES in Males After NES/T With a T-shirt and After Washing
PK of Nestorone in males after wearing a T shirt and after washing will be compared to serum Nestorone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration)
Measured: Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Average Testosterone Levels 90 and 150 Minutes After Each Application in Men
Average testosterone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with showering (Visit 5) and without showering (Visit 7).
Measured: Visits 5 and 7 (Days 8 and 15)
Average Nestorone Levels 90 and 150 Minutes After Each Application in Men
Average Nestorone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with showering (Visit 5) and without showering (Visit 7).
Measured: Visits 5 and 7 (Days 8 and 15)
Incidence of Adverse Events and Serious Adverse Events for Males
Male AEs
Measured: 31 days
Incidence of Adverse Events and Serious Adverse Events for Females
Female AEs
Measured: 31 days
Changes From Baseline in Hematology Safety Labs for Females
Changes from baseline in hematology parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15)
Measured: Screening and Visit 7, up to 43 days
Changes From Baseline in Hematology Safety Labs for Males
Changes from baseline in hematology parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15)
Measured: Screening and Visit 7, up to 43 days
Changes From Baseline in Clinical Chemistry Safety Labs for Females
Changes from baseline in clinical chemistry parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15)
Measured: Screening and Visit 7, up to 43 days
Changes From Baseline in Clinical Chemistry Safety Labs for Males
Changes from baseline in clinical chemistry parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15)
Measured: Screening and Visit 7, up to 43 days
Percentage of Females With Increased (Relative to Baseline) Hirsutism at Each Visit.
Female hirsutism changes assessed at Screening, Visits 4, 6, 8, and 9
Measured: Screening, Visit 4 (Day 3), Visit 6 (Day 10), Visit 8 (Day 17), and Visit 9 (Day 31)
Percentage of Females With Increased (Relative to Baseline) Acne at Each Visit.
Female acne changes assessed at Screening, Visits 4, 6, 8, and 9
Measured: Screening, Visit 4 (Day 3), Visit 6 (Day 10), Visit 8 (Day 17), and Visit 9 (Day 31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly Myer
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Washington, Population Council
- Responsible party
- Sponsor-investigator, Kimberly Myer, Premier Research
- Investigators
- Christina Wang, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterBradley Anawalt, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994602
- Sponsor's protocol ID
- CCN005B
- Other IDs
- HHSN275201200002I
- Acronym
- CCN005B
- Status last verified
- Feb 2018
- First submitted
- 18 Nov 2016
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.
PubMed 10386821Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab. 1996 Feb;81(2):757-62. doi: 10.1210/jcem.81.2.8636300.
PubMed 8636300Brachet C, Vermeulen J, Heinrichs C. Children's virilization and the use of a testosterone gel by their fathers. Eur J Pediatr. 2005 Oct;164(10):646-7. doi: 10.1007/s00431-005-1714-z. Epub 2005 Jul 16.
PubMed 16025298Brache V, Massai R, Mishell DR, Moo-Young AJ, Alvarez F, Salvatierra AM, Cochon L, Croxatto H, Robbins A, Faundes A. Ovarian function during use of Nestorone(R) subdermal implants. Contraception. 2000 Mar;61(3):199-204. doi: 10.1016/s0010-7824(00)00092-5.
PubMed 10827334Cummings DE, Bremner WJ. Prospects for new hormonal male contraceptives. Endocrinol Metab Clin North Am. 1994 Dec;23(4):893-922.
PubMed 7705326de Ronde W, Vogel S, Bui HN, Heijboer AC. Reduction in 24-hour plasma testosterone levels in subjects who showered 15 or 30 minutes after application of testosterone gel. Pharmacotherapy. 2011 Mar;31(3):248-52. doi: 10.1592/phco.31.3.248.
PubMed 21361734Diaz S, Schiappacasse V, Pavez M, Zepeda A, Moo-Young AJ, Brandeis A, Lahteenmaki P, Croxatto HB. Clinical trial with Nestorone subdermal contraceptive implants. Contraception. 1995 Jan;51(1):33-8. doi: 10.1016/0010-7824(94)00006-i.
PubMed 7750282Dorman E, Bishai D. Demand for male contraception. Expert Rev Pharmacoecon Outcomes Res. 2012 Oct;12(5):605-13. doi: 10.1586/erp.12.52.
PubMed 23186401Fraser IS, Weisberg E, Kumar N, Kumar S, Humberstone AJ, McCrossin L, Shaw D, Tsong YY, Sitruk-Ware R. An initial pharmacokinetic study with a Metered Dose Transdermal Systemfor delivery of the progestogen Nestorone as a possible future contraceptive. Contraception. 2007 Dec;76(6):432-8. doi: 10.1016/j.contraception.2007.08.006. Epub 2007 Nov 9.
PubMed 18061700Handelsman DJ, Conway AJ, Howe CJ, Turner L, Mackey MA. Establishing the minimum effective dose and additive effects of depot progestin in suppression of human spermatogenesis by a testosterone depot. J Clin Endocrinol Metab. 1996 Nov;81(11):4113-21. doi: 10.1210/jcem.81.11.8923869.
PubMed 8923869Haukkamaa M, Laurikka-Routti M, Heikinheimo O, Moo-Young A. Contraception with subdermal implants releasing the progestin ST-1435: a dose-finding study. Contraception. 1992 Jan;45(1):49-55. doi: 10.1016/0010-7824(92)90140-o.
PubMed 1591921Heinemann K, Saad F, Wiesemes M, White S, Heinemann L. Attitudes toward male fertility control: results of a multinational survey on four continents. Hum Reprod. 2005 Feb;20(2):549-56. doi: 10.1093/humrep/deh574. Epub 2004 Dec 17.
PubMed 15608042Ilani N, Liu PY, Swerdloff RS, Wang C. Does ethnicity matter in male hormonal contraceptive efficacy? Asian J Androl. 2011 Jul;13(4):579-84. doi: 10.1038/aja.2010.133. Epub 2011 Feb 14.
PubMed 21317912Ilani N, Roth MY, Amory JK, Swerdloff RS, Dart C, Page ST, Bremner WJ, Sitruk-Ware R, Kumar N, Blithe DL, Wang C. A new combination of testosterone and nestorone transdermal gels for male hormonal contraception. J Clin Endocrinol Metab. 2012 Oct;97(10):3476-86. doi: 10.1210/jc.2012-1384. Epub 2012 Jul 12.
PubMed 22791756Kamischke A, Ploger D, Venherm S, von Eckardstein S, von Eckardstein A, Nieschlag E. Intramuscular testosterone undecanoate with or without oral levonorgestrel: a randomized placebo-controlled feasibility study for male contraception. Clin Endocrinol (Oxf). 2000 Jul;53(1):43-52. doi: 10.1046/j.1365-2265.2000.01024.x.
PubMed 10931079
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males: Effect of Washing or Clothing Barrier to the Application
- ClinicalTrials.gov ID
- NCT02994602
- Acronym / sponsor ID
- CCN005B / CCN005B
- Conditions
- Healthy Men, Male Contraception, Healthy Women, Product Transference
- Keywords
- Healthy Men, Male Contraception, Healthy Women, Transfer, Transference, Gel, Nestorone, Testosterone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kimberly MyerUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Washington, Population Council
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.
Detailed description
This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15.
On day 1, the male participant will wear a 100% cotton T-shirt over the application area before skin contact with the female.
On day 8, the male participant will shower approximately 1 hour and 45 minutes after gel application and engage in skin contact with the female participant (2 hours after gel application) after washing the area with soap and water then drying it. A measurement of residual Nestorone and testosterone will be taken from the male's skin on a single location of the application site using adhesive D-square strips 90 minutes after application (30 minutes before shower/90 minutes after gel application) and 30 minutes after the shower and rubbing (150 minutes after application).
On day 15, there will be no shower or clothing barrier for the male participant before skin contact with the female participant. A measurement of residual Nestorone and testosterone will be taken from a single location of the application using adhesive D-square strips site 90 minutes and 150 minutes after the application.
An end of study/exit visit will occur for both male and female participants two weeks after treatment completion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nestorone (NES) + testosterone (T) combined gel | Experimental | Drug: Nestorone + Testosterone Combination GelA combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;
- 18 to 50 years of age;
- BMI ≥ 18 and < 35 kg/m2;
- No history of androgen use prior to the first screening visit as follows:
- Agreement to use a recognized effective method of short acting contraception with his partner (i.e. at a minimum use double-barrier method such as a condom with spermicide) during the entire study;
Key exclusion criteria (37 listed)
- Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
- Men not living in the catchment area of the study site or within a reasonable travel time from the site.
- Any clinically significant abnormal findings at screening per the Investigator's medical judgement.
- Elevated PSA (e.g. levels ≥ 4 ng/mL), according to study site's local laboratory reference normal values for adult men.
- Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction. Other abnormal laboratory values may also be exclusionary, if so considered by the investigator to be clinically significant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nestorone + Testosterone Combination GelAlso: NES/T gel, NES8/T60The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). | Drug | Nestorone (NES) + testosterone (T) combined gel |
Primary outcome
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Time frame: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Time frame: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Time frame: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Time frame: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Time frame: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel
Time frame: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
12 secondary outcomes
PK of T in Males After NES/T With a T-shirt and After Washing
Time frame: Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
PK of NES in Males After NES/T With a T-shirt and After Washing
Time frame: Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)
Average Testosterone Levels 90 and 150 Minutes After Each Application in Men
Time frame: Visits 5 and 7 (Days 8 and 15)
Average Nestorone Levels 90 and 150 Minutes After Each Application in Men
Time frame: Visits 5 and 7 (Days 8 and 15)
Incidence of Adverse Events and Serious Adverse Events for Males
Time frame: 31 days
Incidence of Adverse Events and Serious Adverse Events for Females
Time frame: 31 days
Changes From Baseline in Hematology Safety Labs for Females
Time frame: Screening and Visit 7, up to 43 days
Changes From Baseline in Hematology Safety Labs for Males
Time frame: Screening and Visit 7, up to 43 days
Changes From Baseline in Clinical Chemistry Safety Labs for Females
Time frame: Screening and Visit 7, up to 43 days
Changes From Baseline in Clinical Chemistry Safety Labs for Males
Time frame: Screening and Visit 7, up to 43 days
Percentage of Females With Increased (Relative to Baseline) Hirsutism at Each Visit.
Time frame: Screening, Visit 4 (Day 3), Visit 6 (Day 10), Visit 8 (Day 17), and Visit 9 (Day 31)
Percentage of Females With Increased (Relative to Baseline) Acne at Each Visit.
Time frame: Screening, Visit 4 (Day 3), Visit 6 (Day 10), Visit 8 (Day 17), and Visit 9 (Day 31)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10386821Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.
- Background: PubMed 8636300Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab. 1996 Feb;81(2):757-62. doi: 10.1210/jcem.81.2.8636300.
- Background: PubMed 16025298Brachet C, Vermeulen J, Heinrichs C. Children's virilization and the use of a testosterone gel by their fathers. Eur J Pediatr. 2005 Oct;164(10):646-7. doi: 10.1007/s00431-005-1714-z. Epub 2005 Jul 16.
- Background: PubMed 10827334Brache V, Massai R, Mishell DR, Moo-Young AJ, Alvarez F, Salvatierra AM, Cochon L, Croxatto H, Robbins A, Faundes A. Ovarian function during use of Nestorone(R) subdermal implants. Contraception. 2000 Mar;61(3):199-204. doi: 10.1016/s0010-7824(00)00092-5.
- Background: PubMed 7705326Cummings DE, Bremner WJ. Prospects for new hormonal male contraceptives. Endocrinol Metab Clin North Am. 1994 Dec;23(4):893-922.
- Background: PubMed 21361734de Ronde W, Vogel S, Bui HN, Heijboer AC. Reduction in 24-hour plasma testosterone levels in subjects who showered 15 or 30 minutes after application of testosterone gel. Pharmacotherapy. 2011 Mar;31(3):248-52. doi: 10.1592/phco.31.3.248.
- Background: PubMed 7750282Diaz S, Schiappacasse V, Pavez M, Zepeda A, Moo-Young AJ, Brandeis A, Lahteenmaki P, Croxatto HB. Clinical trial with Nestorone subdermal contraceptive implants. Contraception. 1995 Jan;51(1):33-8. doi: 10.1016/0010-7824(94)00006-i.
- Background: PubMed 23186401Dorman E, Bishai D. Demand for male contraception. Expert Rev Pharmacoecon Outcomes Res. 2012 Oct;12(5):605-13. doi: 10.1586/erp.12.52.
- Background: PubMed 18061700Fraser IS, Weisberg E, Kumar N, Kumar S, Humberstone AJ, McCrossin L, Shaw D, Tsong YY, Sitruk-Ware R. An initial pharmacokinetic study with a Metered Dose Transdermal Systemfor delivery of the progestogen Nestorone as a possible future contraceptive. Contraception. 2007 Dec;76(6):432-8. doi: 10.1016/j.contraception.2007.08.006. Epub 2007 Nov 9.
- Background: PubMed 8923869Handelsman DJ, Conway AJ, Howe CJ, Turner L, Mackey MA. Establishing the minimum effective dose and additive effects of depot progestin in suppression of human spermatogenesis by a testosterone depot. J Clin Endocrinol Metab. 1996 Nov;81(11):4113-21. doi: 10.1210/jcem.81.11.8923869.
- Background: PubMed 1591921Haukkamaa M, Laurikka-Routti M, Heikinheimo O, Moo-Young A. Contraception with subdermal implants releasing the progestin ST-1435: a dose-finding study. Contraception. 1992 Jan;45(1):49-55. doi: 10.1016/0010-7824(92)90140-o.
- Background: PubMed 15608042Heinemann K, Saad F, Wiesemes M, White S, Heinemann L. Attitudes toward male fertility control: results of a multinational survey on four continents. Hum Reprod. 2005 Feb;20(2):549-56. doi: 10.1093/humrep/deh574. Epub 2004 Dec 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Wang, MD principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Bradley Anawalt, MD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nestorone + Testosterone Combination Gel in people with Healthy Men and Male Contraception, run by Kimberly Myer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel (time frame: Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994602, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.