Hypoactive Sexual Desire DisorderPhase 2NCT06082817
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
A Phase 2 study testing Oral Testosterone Undecanoate in people with Hypoactive Sexual Desire Disorder, run by San Diego Sexual Medicine at 1 site in United States.
Trial summary
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Eligible subjects will receive 50 mg capsules of Kyzatrax® to be taken orally daily over a 3-month period. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Oral Testosterone Undecanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant provides written informed consent and HIPAA authorization before any study procedures are conducted;
- Participant is female;
- Participant is aged 30 years or greater;
- Participant is menopausal either spontaneously (at least 12 months amenorrheic or 6 months amenorrheic and FSH >40 IU/ml) or 6 weeks after bilateral salpingo-oophorectomy with or without hysterectomy.
- Participant has a body mass index (BMI) ≤ 34 kg/m2;
- Participant has a diagnosis of hypoactive sexual desire disorder;
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- At screening, participant has a testosterone concentration <30 ng/dL;
- Participant has a normal PAP smear within 6 months of first administration of study drug if participant has a cervix;
- Participant has a normal mammogram within 6 months of first administration of study drug;
- Participant agrees to comply with the study procedures and visits.
Who cannot join
- Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, or titanium dioxide (the constituents of Kyzatrex capsule);
- Participant has received intramuscular testosterone injections, oral or transdermal testosterone within 4 weeks, or subcutaneous testosterone pellet within 6 months prior to the screening visit, or receives any form of testosterone other than study drug during this trial;
- Participant has documented or suspected breast cancer, history of heart attack or stroke;
- Participant has a clinically significant history of disease which could alter absorption, distribution, metabolism, or elimination, such as hepatic, renal, hematologic, gastrointestinal, respiratory, endocrine, or neurological disease;
- Participant has an EKG with an abnormality of clinical significance;
- Participant has an abnormal PAP smear if she has a cervix;
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- Participant has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
- Participant requires major surgery within 4 weeks before signing consent or at any time during the study;
- Participant requires a treatment with any medication listed in Appendix 1 at any time between 30 days before study drug is started or any time until the end of the study;
- Participant has a history of substance abuse within 12 months prior to signing consent;
- Participant has received an investigational drug within 30 days prior to signing consent;
- Participant has any condition or exhibits behavior that indicates to the Principal Investigator that the participant is unlikely to be compliant with study procedures and visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Diego Sexual Medicine
San Diego, California, 92120
About this study
Official title: An Open-Label Pilot Study of the Pharmacokinetics and Safety of 50 Mg Oral Testosterone Undecanoate (Kyzatrex) in Menopausal Women with Low Testosterone and Hypoactive Sexual Desire Disorder
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Eligible subjects will receive 50 mg capsules of Kyzatrax® to be taken orally daily over a 3-month period. Multiple blood samples will be taken at baseline and on days 7, 28 and 56 to assess safety and pharmacokinetics of the testosterone. After the informed consent is signed and for up to 14 days after the last dose of study drug, participants will have serial blood samples collected in addition to other routine study procedures (e.g. vital signs measured, adverse events assessed, validated outcome scales completed).
Read the detailed description
This study is being conducted in an unblinded fashion because the primary endpoint is pharmacokinetic information, and all subjects will receive the same active drug at the same dosage. The primary objectives of this study are to assess the short-term safety and to investigate the pharmacokinetics of serum concentration of total testosterone with daily administration of one (1) 50 mg capsule of testosterone undecanoate (Kyzatrax®) in thirty menopausal women with hypoactive sexual desire disorder (HSDD) and low testosterone. The secondary objective of this study is to assess the efficacy of daily oral administration of one (1) 50 mg capsule of testosterone undecanoate (Kyzatrax®) in thirty menopausal women with HSDD and low testosterone.
The eligibility criterion for testosterone concentration (< 25 ng/mL [< 0.87 nmol/L]) is based on the lower limit of the normal testosterone reference range for adult females. The dose of 50 mg was chosen because this is the lowest oral testosterone currently being manufactured and it represents 12.5% of the starting dose of Kyzatrex FDA approved for men (see Attachment 1). Based on the guidelines of the International Society for the Study of Women's Sexual Health, the starting dose of testosterone for peri- and post-menopausal women is approximately 10% of a testosterone product FDA approved for men. In clinical practice, women are typically prescribed testosterone therapy at 10-20% of the dose given to men, depending on individual adsorption and metabolism characteristics.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Oral Testosterone Undecanoate
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Testosterone UndecanoateDrug
Also called Kyzatrex
50mg oral testosterone undecanoate daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Participants will receive 50mg oral testosterone undecanoate daily, have pharmacokinetics assessed and complete validated instruments Receives: Drug: Oral Testosterone Undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone
serum concentration of total testosterone to assess safety (adverse events) and pharmacokinetics
Measured: days 0, 7, 28, 56
Secondary outcomes (1)
Female Sexual Function Index
Female Sexual Function Index to assess changes in each domain and total, total range 2-36, lower the score the more dysfunction therefore worse function
Measured: Days 0, 28, 56, 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypoactive Sexual Desire DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label 50mg daily dosing with pharmacokinetics assessed by multiple blood draws
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego Sexual Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irwin Goldstein, MD, Principal investigator, San Diego Sexual Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082817
- Sponsor's protocol ID
- SDSM-2023-03
- Status last verified
- Nov 2024
- First submitted
- 8 Oct 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clayton AH, Goldstein I, Kim NN, Althof SE, Faubion SS, Faught BM, Parish SJ, Simon JA, Vignozzi L, Christiansen K, Davis SR, Freedman MA, Kingsberg SA, Kirana PS, Larkin L, McCabe M, Sadovsky R. The International Society for the Study of Women's Sexual Health Process of Care for Management of Hypoactive Sexual Desire Disorder in Women. Mayo Clin Proc. 2018 Apr;93(4):467-487. doi: 10.1016/j.mayocp.2017.11.002. Epub 2018 Mar 12.
PubMed 29545008Parish SJ, Simon JA, Davis SR, Giraldi A, Goldstein I, Goldstein SW, Kim NN, Kingsberg SA, Morgentaler A, Nappi RE, Park K, Stuenkel CA, Traish AM, Vignozzi L. International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med. 2021 May;18(5):849-867. doi: 10.1016/j.jsxm.2020.10.009. Epub 2021 Apr 1.
PubMed 33814355Bachmann G, Bancroft J, Braunstein G, Burger H, Davis S, Dennerstein L, Goldstein I, Guay A, Leiblum S, Lobo R, Notelovitz M, Rosen R, Sarrel P, Sherwin B, Simon J, Simpson E, Shifren J, Spark R, Traish A; Princeton. Female androgen insufficiency: the Princeton consensus statement on definition, classification, and assessment. Fertil Steril. 2002 Apr;77(4):660-5. doi: 10.1016/s0015-0282(02)02969-2.
PubMed 11937111Davis SR, Wahlin-Jacobsen S. Testosterone in women--the clinical significance. Lancet Diabetes Endocrinol. 2015 Dec;3(12):980-92. doi: 10.1016/S2213-8587(15)00284-3. Epub 2015 Sep 7.
PubMed 26358173White WB, Bernstein JS, Rittmaster R, Dhingra O. Effects of the oral testosterone undecanoate Kyzatrex on ambulatory blood pressure in hypogonadal men. J Clin Hypertens (Greenwich). 2021 Jul;23(7):1420-1430. doi: 10.1111/jch.14297. Epub 2021 Jun 11.
PubMed 34114726Asghar AA, Hashmi MR, Ahmed R, Khabir Y. Kyzatrex - Oral testosterone replacement therapy. Ann Med Surg (Lond). 2022 Sep 11;82:104625. doi: 10.1016/j.amsu.2022.104625. eCollection 2022 Oct. No abstract available.
PubMed 36268410
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study of the Pharmacokinetics and Safety of 50 Mg Oral Testosterone Undecanoate (Kyzatrex) in Menopausal Women with Low Testosterone and Hypoactive Sexual Desire Disorder
- ClinicalTrials.gov ID
- NCT06082817
- Acronym / sponsor ID
- SDSM-2023-03
- Conditions
- Hypoactive Sexual Desire Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- San Diego Sexual MedicineUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Oct 2023 (actual)
- 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.
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Eligible subjects will receive 50 mg capsules of Kyzatrax® to be taken orally daily over a 3-month period. Multiple blood samples will be taken at baseline and on days 7, 28 and 56 to assess safety and pharmacokinetics of the testosterone. After the informed consent is signed and for up to 14 days after the last dose of study drug, participants will have serial blood samples collected in addition to other routine study procedures (e.g. vital signs measured, adverse events assessed, validated outcome scales completed).
Detailed description
This study is being conducted in an unblinded fashion because the primary endpoint is pharmacokinetic information, and all subjects will receive the same active drug at the same dosage. The primary objectives of this study are to assess the short-term safety and to investigate the pharmacokinetics of serum concentration of total testosterone with daily administration of one (1) 50 mg capsule of testosterone undecanoate (Kyzatrax®) in thirty menopausal women with hypoactive sexual desire disorder (HSDD) and low testosterone. The secondary objective of this study is to assess the efficacy of daily oral administration of one (1) 50 mg capsule of testosterone undecanoate (Kyzatrax®) in thirty menopausal women with HSDD and low testosterone.
The eligibility criterion for testosterone concentration (< 25 ng/mL [< 0.87 nmol/L]) is based on the lower limit of the normal testosterone reference range for adult females. The dose of 50 mg was chosen because this is the lowest oral testosterone currently being manufactured and it represents 12.5% of the starting dose of Kyzatrex FDA approved for men (see Attachment 1). Based on the guidelines of the International Society for the Study of Women's Sexual Health, the starting dose of testosterone for peri- and post-menopausal women is approximately 10% of a testosterone product FDA approved for men. In clinical practice, women are typically prescribed testosterone therapy at 10-20% of the dose given to men, depending on individual adsorption and metabolism characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label 50mg daily dosing with pharmacokinetics assessed by multiple blood draws
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Oral Testosterone UndecanoateParticipants will receive 50mg oral testosterone undecanoate daily, have pharmacokinetics assessed and complete validated instruments |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant provides written informed consent and HIPAA authorization before any study procedures are conducted;
- Participant is female;
- Participant is aged 30 years or greater;
- Participant is menopausal either spontaneously (at least 12 months amenorrheic or 6 months amenorrheic and FSH >40 IU/ml) or 6 weeks after bilateral salpingo-oophorectomy with or without hysterectomy.
- Participant has a body mass index (BMI) ≤ 34 kg/m2;
Key exclusion criteria (12 listed)
- Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, or titanium dioxide (the constituents of Kyzatrex capsule);
- Participant has received intramuscular testosterone injections, oral or transdermal testosterone within 4 weeks, or subcutaneous testosterone pellet within 6 months prior to the screening visit, or receives any form of testosterone other than study drug during this trial;
- Participant has documented or suspected breast cancer, history of heart attack or stroke;
- Participant has a clinically significant history of disease which could alter absorption, distribution, metabolism, or elimination, such as hepatic, renal, hematologic, gastrointestinal, respiratory, endocrine, or neurological disease;
- Participant has an EKG with an abnormality of clinical significance;
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 |
|---|---|---|
| Oral Testosterone UndecanoateAlso: Kyzatrex50mg oral testosterone undecanoate daily | Drug | Active |
Primary outcome
Testosterone
Time frame: days 0, 7, 28, 56
serum concentration of total testosterone to assess safety (adverse events) and pharmacokinetics
1 secondary outcome
Female Sexual Function Index
Time frame: Days 0, 28, 56, 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Background: PubMed 29545008Clayton AH, Goldstein I, Kim NN, Althof SE, Faubion SS, Faught BM, Parish SJ, Simon JA, Vignozzi L, Christiansen K, Davis SR, Freedman MA, Kingsberg SA, Kirana PS, Larkin L, McCabe M, Sadovsky R. The International Society for the Study of Women's Sexual Health Process of Care for Management of Hypoactive Sexual Desire Disorder in Women. Mayo Clin Proc. 2018 Apr;93(4):467-487. doi: 10.1016/j.mayocp.2017.11.002. Epub 2018 Mar 12.
- Background: PubMed 33814355Parish SJ, Simon JA, Davis SR, Giraldi A, Goldstein I, Goldstein SW, Kim NN, Kingsberg SA, Morgentaler A, Nappi RE, Park K, Stuenkel CA, Traish AM, Vignozzi L. International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med. 2021 May;18(5):849-867. doi: 10.1016/j.jsxm.2020.10.009. Epub 2021 Apr 1.
- Background: PubMed 11937111Bachmann G, Bancroft J, Braunstein G, Burger H, Davis S, Dennerstein L, Goldstein I, Guay A, Leiblum S, Lobo R, Notelovitz M, Rosen R, Sarrel P, Sherwin B, Simon J, Simpson E, Shifren J, Spark R, Traish A; Princeton. Female androgen insufficiency: the Princeton consensus statement on definition, classification, and assessment. Fertil Steril. 2002 Apr;77(4):660-5. doi: 10.1016/s0015-0282(02)02969-2.
- Background: PubMed 26358173Davis SR, Wahlin-Jacobsen S. Testosterone in women--the clinical significance. Lancet Diabetes Endocrinol. 2015 Dec;3(12):980-92. doi: 10.1016/S2213-8587(15)00284-3. Epub 2015 Sep 7.
- Background: PubMed 34114726White WB, Bernstein JS, Rittmaster R, Dhingra O. Effects of the oral testosterone undecanoate Kyzatrex on ambulatory blood pressure in hypogonadal men. J Clin Hypertens (Greenwich). 2021 Jul;23(7):1420-1430. doi: 10.1111/jch.14297. Epub 2021 Jun 11.
- Background: PubMed 36268410Asghar AA, Hashmi MR, Ahmed R, Khabir Y. Kyzatrex - Oral testosterone replacement therapy. Ann Med Surg (Lond). 2022 Sep 11;82:104625. doi: 10.1016/j.amsu.2022.104625. eCollection 2022 Oct. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
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.
Irwin Goldstein, MD principal investigator
San Diego Sexual Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Testosterone Undecanoate in people with Hypoactive Sexual Desire Disorder, run by San Diego Sexual Medicine at 1 site 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 12 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: opening soon, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sue W Goldstein, BA (619-265-8865, suewgoldstein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone (time frame: days 0, 7, 28, 56). 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 NCT06082817, which also lists 6 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 13 Nov 2024.