Healthy MenPhase 1CCN014NCT02754687
Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
A Phase 1 study testing 11βmethyl nortestosterone dodecylcarbonate in people with Healthy Men and Male Contraception, run by Premier Research at 2 sites in United States.
Trial summary
The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men, Male Contraception
- What is being tested?
- 11βmethyl nortestosterone dodecylcarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2016to 5 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening.
- 18 to 50 years of age (inclusive).
- BMI ≤ 33 calculated as weight in kg/ (height in m2).
- No history of hormonal therapy use in the last three months prior to the first screening visit.
- Subject agrees to use a recognized effective method of contraception with any female partner (i.e. at a minimum, use barrier plus and additional method of contraception) during the course of the study treatment and recovery phase.
- Subjects will refrain from donating blood or plasma during the study period.
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- Subjects will be advised to refrain/abstain from alcoholic beverages and grapefruit juice during the study period.
- Subjects will not use cannabis or any recreational drugs at least 2 weeks before completing screening and during the study.
- In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form.
- Does not meet any of the exclusion criteria.
Who cannot join
- 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 clinic or within a reasonable distance from the study site.
- Clinically significant abnormal physical and laboratory findings at screening.
- Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
- Abnormal serum chemistry values, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant except for: an upper limit for fasting bilirubin less than 2 mg/dL, upper limit for cholesterol less than 221 mg/dL, or upper limit for fasting triglycerides less than 201 mg/dL.
- Use of androgens within 2 months before first screening visit.
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- Ongoing use of body building nutritional supplements.
- Systolic BP > 135 mm Hg and Diastolic blood pressure BP > 85 and mm Hg; ((BP) Blood pressure will be taken 3 times at 5 - minute intervals and the mean of all measurements be considered).
- Clinically significant abnormal EKG or a QTc interval of > 450 msec.
- History of hypertension, including hypertension controlled with treatment.
- Benign or malignant liver tumors; active liver disease.
- History of breast carcinoma.
- Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
- Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
- Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.
- A serious systemic disease such as diabetes mellitus or obesity (body weight greater than BMI >33 kg/m2 as above).
- History of known, untreated sleep apnea.
- Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones or study treatment compliance.
- Partner is known to be pregnant.
- Men desiring fertility within the first 24 weeks of study participation.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Washington
Seattle, Washington, 98195
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Single Dose, Dose-Ranging Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.
Read the detailed description
This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men followed on an inpatient basis to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of 11β-methyl nortestosterone dodecylcarbonate (11β-MNTDC).
This single dose, dose-ranging study of 4 escalating doses will be conducted in two centers.
Initially, 12 men will be enrolled in total, 6 men at each center, with a goal of having a minimum of 12 healthy male subjects completing this study (10 active drugs and 2 placebos) both in the fed and fasting states at each dose.
Each of the 4 doses of 11β-MNTDC will be administered first fasting and then fed. Each of the doses of 11β-MNTDC will be administered about 28 days apart +/- 14 days with the time interval between the fasting and fed dosing will be approximately 7 days (-2/+9 days) and a 7 to 14 day washout will occur before dose escalation.
- Conditions
- Healthy Men, Male Contraception
- Being tested
- Placebo, 11βmethyl nortestosterone dodecylcarbonate
- Keywords
- male contraception, healthy men, androgen, Nortestosterone, Dodecylcarbonate, 11-Beta, 11β, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo with capsules that look like the 11β-MNTDC capsules but with no active ingredients
11βmethyl nortestosterone dodecylcarbonateDrug
Also called 11β-MNTDC
Escalating doses of 100, 200, 400, and 800 mg 11β-MNTDC
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| 11βmethyl nortestosterone dodecylcarbonate | Experimental | 11β-MNTDC in doses of 100 mg, 200 mg, 400 mg, and 800 mg Receives: Drug: 11βmethyl nortestosterone dodecylcarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by adverse events
As by adverse events
Measured: 12-20 weeks
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in vital signs
As by changes from baseline in vital signs
Measured: 12-20 weeks
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in electrocardiogram (EKG)
As by changes from baseline in EKG
Measured: 12-20 weeks
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in physical exams
As by changes from baseline in physical exams
Measured: 12-20 weeks
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in lab tests
As by changes from baseline in lab tests
Measured: 12-20 weeks
Secondary outcomes (13)
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using area under the curve (AUC)
11β-MNTDC PK levels at various time points through the 112 days of treatment using AUC
Measured: 112 days
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using maximum concentration (Cmax)
11β-MNTDC PK levels at various time points through the 112 days of treatment using Cmax
Measured: 112 days
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using Time to Reach Maximum Concentration (Tmax)
11β-MNTDC PK levels at various time points through the 112 days of treatment using Tmax
Measured: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Luteinizing Hormone (LH)
11β-MNTDC PD levels at various time points through the 112 days of treatment
Measured: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Follicle Stimulating Hormone (FSH)
11β-MNTDC PD levels at various time points through the 112 days of treatment
Measured: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Testosterone (T)
11β-MNTDC PD levels at various time points through the 112 days of treatment
Measured: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by free Testosterone (free T)
11β-MNTDC PD levels at various time points through the 112 days of treatment
Measured: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Dihydrotestosterone (DHT)
11β-MNTDC PD levels at various time points through the 112 days of treatment
Measured: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by estradiol (E2)
11β-MNTDC PD levels at various time points through the 112 days of treatment
Measured: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Sex Hormone Binding Globulin (SHBG)
11β-MNTDC PD levels at various time points through the 112 days of treatment
Measured: 112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using Average Concentration (Cavg)
Comparison of pharmacokinetic measures among the single dose periods and comparison of PK parameters in the fed and fasting states will be performed with mixed model repeated measures analysis of variance (ANOVA). Evidence of lack of food effect will be concluded if ANOVA-estimated PK parameters (Cavg) after food are within 80 to 125% of those obtained at the fasting state.
Measured: 112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using the area under the curve from 0-24 hours (AUC 0-24h)
Comparison of pharmacokinetic measures among the single dose periods and comparison of PK parameters in the fed and fasting states will be performed with mixed model repeated measures analysis of variance (ANOVA). Evidence of lack of food effect will be concluded if ANOVA-estimated PK parameters (AUC0-24h) after food are within 80 to 125% of those obtained at the fasting state.
Measured: 112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using maximum concentration (Cmax)
Comparison of pharmacokinetic measures among the single dose periods and comparison of PK parameters in the fed and fasting states will be performed with mixed model repeated measures analysis of variance (ANOVA). Evidence of lack of food effect will be concluded if ANOVA-estimated PK parameters (Cmax) after food are within 80 to 125% of those obtained at the fasting state.
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start14 Jul 2016
- Primary completion23 Jan 2017
- Study completion5 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premier Research
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Responsible party
- Sponsor
- Investigators
- Christina Wang, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterStephanie Page, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754687
- Sponsor's protocol ID
- CCN014
- Other IDs
- HHSN275201200002I
- Acronym
- CCN014
- Status last verified
- Oct 2025
- First submitted
- 28 Mar 2016
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amory JK, Anawalt BD, Bremner WJ, Matsumoto AM. Daily testosterone and gonadotropin levels are similar in azoospermic and nonazoospermic normal men administered weekly testosterone: implications for male contraceptive development. J Androl. 2001 Nov-Dec;22(6):1053-60. doi: 10.1002/j.1939-4640.2001.tb03445.x.
PubMed 11700852Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. doi: 10.1210/jc.2004-1221. Epub 2005 Feb 15.
PubMed 15713724Anderson RA, Wallace AM, Wu FC. Comparison between testosterone enanthate-induced azoospermia and oligozoospermia in a male contraceptive study. III. Higher 5 alpha-reductase activity in oligozoospermic men administered supraphysiological doses of testosterone. J Clin Endocrinol Metab. 1996 Mar;81(3):902-8. doi: 10.1210/jcem.81.3.8772548.
PubMed 8772548Attardi BJ, Engbring JA, Gropp D, Hild SA. Development of dimethandrolone 17beta-undecanoate (DMAU) as an oral male hormonal contraceptive: induction of infertility and recovery of fertility in adult male rabbits. J Androl. 2011 Sep-Oct;32(5):530-40. doi: 10.2164/jandrol.110.011817. Epub 2010 Dec 16.
PubMed 21164142Attardi BJ, Hild SA, Koduri S, Pham T, Pessaint L, Engbring J, Till B, Gropp D, Semon A, Reel JR. The potent synthetic androgens, dimethandrolone (7alpha,11beta-dimethyl-19-nortestosterone) and 11beta-methyl-19-nortestosterone, do not require 5alpha-reduction to exert their maximal androgenic effects. J Steroid Biochem Mol Biol. 2010 Oct;122(4):212-8. doi: 10.1016/j.jsbmb.2010.06.009. Epub 2010 Jun 25.
PubMed 20599615Attardi BJ, Hild SA, Reel JR. Dimethandrolone undecanoate: a new potent orally active androgen with progestational activity. Endocrinology. 2006 Jun;147(6):3016-26. doi: 10.1210/en.2005-1524. Epub 2006 Feb 23.
PubMed 16497801Attardi BJ, Marck BT, Matsumoto AM, Koduri S, Hild SA. Long-term effects of dimethandrolone 17beta-undecanoate and 11beta-methyl-19-nortestosterone 17beta-dodecylcarbonate on body composition, bone mineral density, serum gonadotropins, and androgenic/anabolic activity in castrated male rats. J Androl. 2011 Mar-Apr;32(2):183-92. doi: 10.2164/jandrol.110.010371. Epub 2010 Aug 26.
PubMed 20798389Attardi BJ, Pham TC, Radler LC, Burgenson J, Hild SA, Reel JR. Dimethandrolone (7alpha,11beta-dimethyl-19-nortestosterone) and 11beta-methyl-19-nortestosterone are not converted to aromatic A-ring products in the presence of recombinant human aromatase. J Steroid Biochem Mol Biol. 2008 Jun;110(3-5):214-22. doi: 10.1016/j.jsbmb.2007.11.009.
PubMed 18555683Bagchus WM, Hust R, Maris F, Schnabel PG, Houwing NS. Important effect of food on the bioavailability of oral testosterone undecanoate. Pharmacotherapy. 2003 Mar;23(3):319-25. doi: 10.1592/phco.23.3.319.32104.
PubMed 12627930Behre H M, Wang C, Handelsman D J & Nieschlag E. (2004) Pharmacology of Testosterone Preparations. In: Testosterone, Vol. Third (eds E Nieschlag & H M Behre), pp. 405-444. Cambridge University Press, Cambridge.
Cook CE, Kepler JA. 7alpha,11beta-Dimethyl-19-nortestosterone: a potent and selective androgen response modulator with prostate-sparing properties. Bioorg Med Chem Lett. 2005 Feb 15;15(4):1213-6. doi: 10.1016/j.bmcl.2004.11.076.
PubMed 15686944Friedl KE, Hannan CJ Jr, Jones RE, Plymate SR. High-density lipoprotein cholesterol is not decreased if an aromatizable androgen is administered. Metabolism. 1990 Jan;39(1):69-74. doi: 10.1016/0026-0495(90)90150-b.
PubMed 2294373Gooren LJ. A ten-year safety study of the oral androgen testosterone undecanoate. J Androl. 1994 May-Jun;15(3):212-5.
PubMed 7928661Gu Y, Liang X, Wu W, Liu M, Song S, Cheng L, Bo L, Xiong C, Wang X, Liu X, Peng L, Yao K. Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men. J Clin Endocrinol Metab. 2009 Jun;94(6):1910-5. doi: 10.1210/jc.2008-1846. Epub 2009 Mar 17.
PubMed 19293262Heckel M J. (1939) Production of oliogspermia in a man by the use of testosterone propionate. Exl. Biol. Med. 40, 658-659.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Dose-Ranging Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
- ClinicalTrials.gov ID
- NCT02754687
- Acronym / sponsor ID
- CCN014 / CCN014
- Conditions
- Healthy Men, Male Contraception
- Keywords
- male contraception, healthy men, androgen, Nortestosterone, Dodecylcarbonate, 11-Beta, 11β, contraception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Premier ResearchUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 23 Jan 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.
Detailed description
This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men followed on an inpatient basis to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of 11β-methyl nortestosterone dodecylcarbonate (11β-MNTDC).
This single dose, dose-ranging study of 4 escalating doses will be conducted in two centers.
Initially, 12 men will be enrolled in total, 6 men at each center, with a goal of having a minimum of 12 healthy male subjects completing this study (10 active drugs and 2 placebos) both in the fed and fasting states at each dose.
Each of the 4 doses of 11β-MNTDC will be administered first fasting and then fed. Each of the doses of 11β-MNTDC will be administered about 28 days apart +/- 14 days with the time interval between the fasting and fed dosing will be approximately 7 days (-2/+9 days) and a 7 to 14 day washout will occur before dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| 11βmethyl nortestosterone dodecylcarbonate | Experimental | Drug: 11βmethyl nortestosterone dodecylcarbonate11β-MNTDC in doses of 100 mg, 200 mg, 400 mg, and 800 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening.
- 18 to 50 years of age (inclusive).
- BMI ≤ 33 calculated as weight in kg/ (height in m2).
- No history of hormonal therapy use in the last three months prior to the first screening visit.
- Subject agrees to use a recognized effective method of contraception with any female partner (i.e. at a minimum, use barrier plus and additional method of contraception) during the course of the study treatment and recovery phase.
Key exclusion criteria (21 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 clinic or within a reasonable distance from the study site.
- Clinically significant abnormal physical and laboratory findings at screening.
- Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
- Abnormal serum chemistry values, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant except for: an upper limit for fasting bilirubin less than 2 mg/dL, upper limit for cholesterol less than 221 mg/dL, or upper limit for fasting triglycerides less than 201 mg/dL.
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 |
|---|---|---|
| PlaceboPlacebo with capsules that look like the 11β-MNTDC capsules but with no active ingredients | Drug | Placebo |
| 11βmethyl nortestosterone dodecylcarbonateAlso: 11β-MNTDCEscalating doses of 100, 200, 400, and 800 mg 11β-MNTDC | Drug | 11βmethyl nortestosterone dodecylcarbonate |
Primary outcome
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by adverse events
Time frame: 12-20 weeks
As by adverse events
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in vital signs
Time frame: 12-20 weeks
As by changes from baseline in vital signs
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in electrocardiogram (EKG)
Time frame: 12-20 weeks
As by changes from baseline in EKG
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in physical exams
Time frame: 12-20 weeks
As by changes from baseline in physical exams
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in lab tests
Time frame: 12-20 weeks
As by changes from baseline in lab tests
13 secondary outcomes
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using area under the curve (AUC)
Time frame: 112 days
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using maximum concentration (Cmax)
Time frame: 112 days
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using Time to Reach Maximum Concentration (Tmax)
Time frame: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Luteinizing Hormone (LH)
Time frame: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Follicle Stimulating Hormone (FSH)
Time frame: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Testosterone (T)
Time frame: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by free Testosterone (free T)
Time frame: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Dihydrotestosterone (DHT)
Time frame: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by estradiol (E2)
Time frame: 112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Sex Hormone Binding Globulin (SHBG)
Time frame: 112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using Average Concentration (Cavg)
Time frame: 112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using the area under the curve from 0-24 hours (AUC 0-24h)
Time frame: 112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using maximum concentration (Cmax)
Time frame: 112 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Background: PubMed 11700852Amory JK, Anawalt BD, Bremner WJ, Matsumoto AM. Daily testosterone and gonadotropin levels are similar in azoospermic and nonazoospermic normal men administered weekly testosterone: implications for male contraceptive development. J Androl. 2001 Nov-Dec;22(6):1053-60. doi: 10.1002/j.1939-4640.2001.tb03445.x.
- Background: PubMed 15713724Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. doi: 10.1210/jc.2004-1221. Epub 2005 Feb 15.
- Background: PubMed 8772548Anderson RA, Wallace AM, Wu FC. Comparison between testosterone enanthate-induced azoospermia and oligozoospermia in a male contraceptive study. III. Higher 5 alpha-reductase activity in oligozoospermic men administered supraphysiological doses of testosterone. J Clin Endocrinol Metab. 1996 Mar;81(3):902-8. doi: 10.1210/jcem.81.3.8772548.
- Background: PubMed 21164142Attardi BJ, Engbring JA, Gropp D, Hild SA. Development of dimethandrolone 17beta-undecanoate (DMAU) as an oral male hormonal contraceptive: induction of infertility and recovery of fertility in adult male rabbits. J Androl. 2011 Sep-Oct;32(5):530-40. doi: 10.2164/jandrol.110.011817. Epub 2010 Dec 16.
- Background: PubMed 20599615Attardi BJ, Hild SA, Koduri S, Pham T, Pessaint L, Engbring J, Till B, Gropp D, Semon A, Reel JR. The potent synthetic androgens, dimethandrolone (7alpha,11beta-dimethyl-19-nortestosterone) and 11beta-methyl-19-nortestosterone, do not require 5alpha-reduction to exert their maximal androgenic effects. J Steroid Biochem Mol Biol. 2010 Oct;122(4):212-8. doi: 10.1016/j.jsbmb.2010.06.009. Epub 2010 Jun 25.
- Background: PubMed 16497801Attardi BJ, Hild SA, Reel JR. Dimethandrolone undecanoate: a new potent orally active androgen with progestational activity. Endocrinology. 2006 Jun;147(6):3016-26. doi: 10.1210/en.2005-1524. Epub 2006 Feb 23.
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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
Stephanie Page, MD, PhD 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 11βmethyl nortestosterone dodecylcarbonate in people with Healthy Men and Male Contraception, run by Premier Research 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 10 inclusion and 21 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 31 Oct 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by adverse events (time frame: 12-20 weeks). The study lists 5 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 NCT02754687, which also lists 36 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 31 Oct 2025.