TransgenderismPhase 4NCT07092527
Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
A Phase 4 study testing Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution in people with Transgenderism and Reproductive Issues, run by University of California, San Diego at 1 site in United States.
Trial summary
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transgenderism, Reproductive Issues
- What is being tested?
- Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to 30 Nov 2028
- Phase
- Phase 4
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged 18-35
- Having regular menstrual cycles (every 24-35 days)
Who cannot join
- Pregnant
- Incarcerated
- Known cognitive impairment or institutionalized
- Hemoglobin less than 11 gm/dl at screening evaluation
- Weight less than 110 pounds
- BMI <18 or >35
Show all 14Show fewer
- Current endocrine disease- including untreated thyroid abnormalities, pituitary or adrenal disease, polycystic ovary syndrome, or androgen producing tumor
- Current or recent pregnancy within two months of study enrollment
- Current or recent breast feeding within two months of study enrollment
- Diabetes, or renal, liver, or heart disease
- History of oophorectomy or hysterectomy
- History of radiation or surgery involving brain structures and/or pelvis/pelvic organs
- Currently taking any medications that may affect their reproductive hormones, such as contraceptive medications, androgens, estrogens, progestins, gonadotropin-releasing hormone (GnRH) antagonists, insulinomimetics, and metformin.
- History of prior testosterone therapy
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, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92037
Antoni Duleba, MD, 619-804-4765, aduleba@health.ucsd.edu
Marisa Hildebrand, MPH, 619-804-4765, mchildeb@health.ucsd.edu
About this study
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
Read the detailed description
Testosterone Replacement Therapy (TRT) is the mainstay of gender affirming care for transgender men (TGM) who have male gender identity after female sex assignment at birth. TGM receiving TRT over time exhibit irregular menstrual bleeding, however, the mechanism of menstrual disruption is unknown. Therefore, the investigators propose to evaluate the effect of chronic testosterone (T) exposure on ovarian hormones and pituitary gonadotropin release that determines menstrual cyclicity. The investigators will conduct a detailed study of blood reproductive hormone secretion in TGM before and during TRT as well as in untreated cisgender female (CGF) control subjects who report female gender identity congruent with female sex assignment at birth. The investigators will also perform periodic clinical and ultrasonographic evaluations.
- Conditions
- Transgenderism, Reproductive Issues
- Being tested
- Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable SolutionDrug
Also called Testosterone Replacement Therapy
Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.
| Study group | Role | What they receive |
|---|---|---|
| Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT) | Active comparator | Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy Receives: Drug: Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution |
| Cisgender Female (CGF) control group | No intervention | Cisgender females serving as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Luteal Activity (ELA)
Evidence of Luteal Activity (ELA), as defined by serum progesterone level above 3 ng/mL in transgender men initiating testosterone replacement therapy.
Measured: Through study completion, an average of 7 months.
Determination of Pulsatile Luteinizing Hormone (LH) Secretion
Subjects will have baseline measurement of serum LH immediately followed by frequent blood sampling at 10-min intervals for 8 h. We will measure LH pulse frequency, the number of LH pulses per 8 hours.
Measured: Through study completion, an average of 7 months.
Uterine Bleeding Pattern
All subjects will complete a daily uterine bleeding log using REDCap®
Measured: Through study completion, an average of 7 months.
Secondary outcomes (5)
Evaluate Serum FSH
Measurement of serum follicle-stimulating hormone (FSH) levels
Measured: Through study completion, an average of 7 months.
Evaluate Serum AMH
Measurement of serum anti-mullerian hormone (AMH) levels
Measured: Through study completion, an average of 7 months.
Evaluate Serum LH
Measurement of serum luteinizing hormone (LH) levels
Measured: Through study completion, an average of 7 months.
Evaluate Serum Estradiol
Measurement of serum estradiol levels
Measured: Through study completion, an average of 7 months.
Evaluate Serum Testosterone
Measurement of serum testosterone levels
Measured: Through study completion, an average of 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start5 Dec 2025
- Primary completion15 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Antoni Duleba, University of California, San Diego
- Investigators
- Antoni Duleba, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092527
- Sponsor's protocol ID
- 813087
- Other IDs
- 1R01HD111650-01
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing individual participant data (IPD).
Publications
Coleman E, Radix AE, Bouman WP, Brown GR, de Vries ALC, Deutsch MB, Ettner R, Fraser L, Goodman M, Green J, Hancock AB, Johnson TW, Karasic DH, Knudson GA, Leibowitz SF, Meyer-Bahlburg HFL, Monstrey SJ, Motmans J, Nahata L, Nieder TO, Reisner SL, Richards C, Schechter LS, Tangpricha V, Tishelman AC, Van Trotsenburg MAA, Winter S, Ducheny K, Adams NJ, Adrian TM, Allen LR, Azul D, Bagga H, Basar K, Bathory DS, Belinky JJ, Berg DR, Berli JU, Bluebond-Langner RO, Bouman MB, Bowers ML, Brassard PJ, Byrne J, Capitan L, Cargill CJ, Carswell JM, Chang SC, Chelvakumar G, Corneil T, Dalke KB, De Cuypere G, de Vries E, Den Heijer M, Devor AH, Dhejne C, D'Marco A, Edmiston EK, Edwards-Leeper L, Ehrbar R, Ehrensaft D, Eisfeld J, Elaut E, Erickson-Schroth L, Feldman JL, Fisher AD, Garcia MM, Gijs L, Green SE, Hall BP, Hardy TLD, Irwig MS, Jacobs LA, Janssen AC, Johnson K, Klink DT, Kreukels BPC, Kuper LE, Kvach EJ, Malouf MA, Massey R, Mazur T, McLachlan C, Morrison SD, Mosser SW, Neira PM, Nygren U, Oates JM, Obedin-Maliver J, Pagkalos G, Patton J, Phanuphak N, Rachlin K, Reed T, Rider GN, Ristori J, Robbins-Cherry S, Roberts SA, Rodriguez-Wallberg KA, Rosenthal SM, Sabir K, Safer JD, Scheim AI, Seal LJ, Sehoole TJ, Spencer K, St Amand C, Steensma TD, Strang JF, Taylor GB, Tilleman K, T'Sjoen GG, Vala LN, Van Mello NM, Veale JF, Vencill JA, Vincent B, Wesp LM, West MA, Arcelus J. Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-S259. doi: 10.1080/26895269.2022.2100644. eCollection 2022.
PubMed 36238954Hembree WC, Cohen-Kettenis PT, Gooren L, Hannema SE, Meyer WJ, Murad MH, Rosenthal SM, Safer JD, Tangpricha V, T'Sjoen GG. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-3903. doi: 10.1210/jc.2017-01658.
PubMed 28945902Deutsch MB, Bhakri V, Kubicek K. Effects of cross-sex hormone treatment on transgender women and men. Obstet Gynecol. 2015 Mar;125(3):605-610. doi: 10.1097/AOG.0000000000000692.
PubMed 25730222McFarland J, Craig W, Clarke NJ, Spratt DI. Serum Testosterone Concentrations Remain Stable Between Injections in Patients Receiving Subcutaneous Testosterone. J Endocr Soc. 2017 Jul 21;1(8):1095-1103. doi: 10.1210/js.2017-00148. eCollection 2017 Aug 1.
PubMed 29264562Nakamura A, Watanabe M, Sugimoto M, Sako T, Mahmood S, Kaku H, Nasu Y, Ishii K, Nagai A, Kumon H. Dose-response analysis of testosterone replacement therapy in patients with female to male gender identity disorder. Endocr J. 2013;60(3):275-81. doi: 10.1507/endocrj.ej12-0319. Epub 2012 Oct 27.
PubMed 23117148Conron KJ, Scott G, Stowell GS, Landers SJ. Transgender health in Massachusetts: results from a household probability sample of adults. Am J Public Health. 2012 Jan;102(1):118-22. doi: 10.2105/AJPH.2011.300315. Epub 2011 Nov 28.
PubMed 22095354Clark TC, Lucassen MF, Bullen P, Denny SJ, Fleming TM, Robinson EM, Rossen FV. The health and well-being of transgender high school students: results from the New Zealand adolescent health survey (Youth'12). J Adolesc Health. 2014 Jul;55(1):93-9. doi: 10.1016/j.jadohealth.2013.11.008. Epub 2014 Jan 14.
PubMed 24438852Kuyper L, Wijsen C. Gender identities and gender dysphoria in the Netherlands. Arch Sex Behav. 2014 Feb;43(2):377-85. doi: 10.1007/s10508-013-0140-y. Epub 2013 Jul 16.
PubMed 23857516Van Caenegem E, Wierckx K, Elaut E, Buysse A, Dewaele A, Van Nieuwerburgh F, De Cuypere G, T'Sjoen G. Prevalence of Gender Nonconformity in Flanders, Belgium. Arch Sex Behav. 2015 Jul;44(5):1281-7. doi: 10.1007/s10508-014-0452-6. Epub 2015 Jan 15.
PubMed 25588709Meerwijk EL, Sevelius JM. Transgender Population Size in the United States: a Meta-Regression of Population-Based Probability Samples. Am J Public Health. 2017 Feb;107(2):e1-e8. doi: 10.2105/AJPH.2016.303578.
PubMed 28075632Meyer IH, Brown TN, Herman JL, Reisner SL, Bockting WO. Demographic Characteristics and Health Status of Transgender Adults in Select US Regions: Behavioral Risk Factor Surveillance System, 2014. Am J Public Health. 2017 Apr;107(4):582-589. doi: 10.2105/AJPH.2016.303648. Epub 2017 Feb 16.
PubMed 28207334De Cuypere G, Van Hemelrijck M, Michel A, Carael B, Heylens G, Rubens R, Hoebeke P, Monstrey S. Prevalence and demography of transsexualism in Belgium. Eur Psychiatry. 2007 Apr;22(3):137-41. doi: 10.1016/j.eurpsy.2006.10.002. Epub 2006 Dec 26.
PubMed 17188846Zucker KJ, Lawrence AA. Epidemiology of Gender Identity Disorder: Recommendations for the Standards of Care of the World Professional Association for Transgender Health. Int J Transgenderism. 2009;11(1):8-18. doi:10.1080/15532730902799946
Coleman E, Bockting W, Botzer M, et al. Standards of Care for the Health of Transsexual, Transgender, and Gender-Nonconforming People, Version 7. Int J Transgenderism. 2012;13(4):165-232. doi:10.1080/15532739.2011.700873
Spinder T, Spijkstra JJ, van den Tweel JG, Burger CW, van Kessel H, Hompes PG, Gooren LJ. The effects of long term testosterone administration on pulsatile luteinizing hormone secretion and on ovarian histology in eugonadal female to male transsexual subjects. J Clin Endocrinol Metab. 1989 Jul;69(1):151-7. doi: 10.1210/jcem-69-1-151.
PubMed 2471710
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
- ClinicalTrials.gov ID
- NCT07092527
- Acronym / sponsor ID
- 813087
- Conditions
- Transgenderism, Reproductive Issues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 30 Jul 2025 (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 research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
Detailed description
Testosterone Replacement Therapy (TRT) is the mainstay of gender affirming care for transgender men (TGM) who have male gender identity after female sex assignment at birth. TGM receiving TRT over time exhibit irregular menstrual bleeding, however, the mechanism of menstrual disruption is unknown. Therefore, the investigators propose to evaluate the effect of chronic testosterone (T) exposure on ovarian hormones and pituitary gonadotropin release that determines menstrual cyclicity. The investigators will conduct a detailed study of blood reproductive hormone secretion in TGM before and during TRT as well as in untreated cisgender female (CGF) control subjects who report female gender identity congruent with female sex assignment at birth. The investigators will also perform periodic clinical and ultrasonographic evaluations.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT) | Active comparator | Drug: Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable SolutionTransgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy |
| Cisgender Female (CGF) control group | No intervention | –Cisgender females serving as a control group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged 18-35
- Having regular menstrual cycles (every 24-35 days)
Key exclusion criteria (14 listed)
- Pregnant
- Incarcerated
- Known cognitive impairment or institutionalized
- Hemoglobin less than 11 gm/dl at screening evaluation
- Weight less than 110 pounds
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 |
|---|---|---|
| Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable SolutionAlso: Testosterone Replacement TherapyParticipants in the initiating group will receive weekly doses of testosterone for gender-affirming care. | Drug | Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT) |
Primary outcome
Evidence of Luteal Activity (ELA)
Time frame: Through study completion, an average of 7 months.
Evidence of Luteal Activity (ELA), as defined by serum progesterone level above 3 ng/mL in transgender men initiating testosterone replacement therapy.
Determination of Pulsatile Luteinizing Hormone (LH) Secretion
Time frame: Through study completion, an average of 7 months.
Subjects will have baseline measurement of serum LH immediately followed by frequent blood sampling at 10-min intervals for 8 h. We will measure LH pulse frequency, the number of LH pulses per 8 hours.
Uterine Bleeding Pattern
Time frame: Through study completion, an average of 7 months.
All subjects will complete a daily uterine bleeding log using REDCap®
5 secondary outcomes
Evaluate Serum FSH
Time frame: Through study completion, an average of 7 months.
Evaluate Serum AMH
Time frame: Through study completion, an average of 7 months.
Evaluate Serum LH
Time frame: Through study completion, an average of 7 months.
Evaluate Serum Estradiol
Time frame: Through study completion, an average of 7 months.
Evaluate Serum Testosterone
Time frame: Through study completion, an average of 7 months.
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 15 Jan 2026.
- Background: PubMed 36238954Coleman E, Radix AE, Bouman WP, Brown GR, de Vries ALC, Deutsch MB, Ettner R, Fraser L, Goodman M, Green J, Hancock AB, Johnson TW, Karasic DH, Knudson GA, Leibowitz SF, Meyer-Bahlburg HFL, Monstrey SJ, Motmans J, Nahata L, Nieder TO, Reisner SL, Richards C, Schechter LS, Tangpricha V, Tishelman AC, Van Trotsenburg MAA, Winter S, Ducheny K, Adams NJ, Adrian TM, Allen LR, Azul D, Bagga H, Basar K, Bathory DS, Belinky JJ, Berg DR, Berli JU, Bluebond-Langner RO, Bouman MB, Bowers ML, Brassard PJ, Byrne J, Capitan L, Cargill CJ, Carswell JM, Chang SC, Chelvakumar G, Corneil T, Dalke KB, De Cuypere G, de Vries E, Den Heijer M, Devor AH, Dhejne C, D'Marco A, Edmiston EK, Edwards-Leeper L, Ehrbar R, Ehrensaft D, Eisfeld J, Elaut E, Erickson-Schroth L, Feldman JL, Fisher AD, Garcia MM, Gijs L, Green SE, Hall BP, Hardy TLD, Irwig MS, Jacobs LA, Janssen AC, Johnson K, Klink DT, Kreukels BPC, Kuper LE, Kvach EJ, Malouf MA, Massey R, Mazur T, McLachlan C, Morrison SD, Mosser SW, Neira PM, Nygren U, Oates JM, Obedin-Maliver J, Pagkalos G, Patton J, Phanuphak N, Rachlin K, Reed T, Rider GN, Ristori J, Robbins-Cherry S, Roberts SA, Rodriguez-Wallberg KA, Rosenthal SM, Sabir K, Safer JD, Scheim AI, Seal LJ, Sehoole TJ, Spencer K, St Amand C, Steensma TD, Strang JF, Taylor GB, Tilleman K, T'Sjoen GG, Vala LN, Van Mello NM, Veale JF, Vencill JA, Vincent B, Wesp LM, West MA, Arcelus J. Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-S259. doi: 10.1080/26895269.2022.2100644. eCollection 2022.
- Background: PubMed 28945902Hembree WC, Cohen-Kettenis PT, Gooren L, Hannema SE, Meyer WJ, Murad MH, Rosenthal SM, Safer JD, Tangpricha V, T'Sjoen GG. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-3903. doi: 10.1210/jc.2017-01658.
- Background: PubMed 25730222Deutsch MB, Bhakri V, Kubicek K. Effects of cross-sex hormone treatment on transgender women and men. Obstet Gynecol. 2015 Mar;125(3):605-610. doi: 10.1097/AOG.0000000000000692.
- Background: PubMed 29264562McFarland J, Craig W, Clarke NJ, Spratt DI. Serum Testosterone Concentrations Remain Stable Between Injections in Patients Receiving Subcutaneous Testosterone. J Endocr Soc. 2017 Jul 21;1(8):1095-1103. doi: 10.1210/js.2017-00148. eCollection 2017 Aug 1.
- Background: PubMed 23117148Nakamura A, Watanabe M, Sugimoto M, Sako T, Mahmood S, Kaku H, Nasu Y, Ishii K, Nagai A, Kumon H. Dose-response analysis of testosterone replacement therapy in patients with female to male gender identity disorder. Endocr J. 2013;60(3):275-81. doi: 10.1507/endocrj.ej12-0319. Epub 2012 Oct 27.
- Background: PubMed 22095354Conron KJ, Scott G, Stowell GS, Landers SJ. Transgender health in Massachusetts: results from a household probability sample of adults. Am J Public Health. 2012 Jan;102(1):118-22. doi: 10.2105/AJPH.2011.300315. Epub 2011 Nov 28.
- Background: PubMed 24438852Clark TC, Lucassen MF, Bullen P, Denny SJ, Fleming TM, Robinson EM, Rossen FV. The health and well-being of transgender high school students: results from the New Zealand adolescent health survey (Youth'12). J Adolesc Health. 2014 Jul;55(1):93-9. doi: 10.1016/j.jadohealth.2013.11.008. Epub 2014 Jan 14.
- Background: PubMed 23857516Kuyper L, Wijsen C. Gender identities and gender dysphoria in the Netherlands. Arch Sex Behav. 2014 Feb;43(2):377-85. doi: 10.1007/s10508-013-0140-y. Epub 2013 Jul 16.
- Background: PubMed 25588709Van Caenegem E, Wierckx K, Elaut E, Buysse A, Dewaele A, Van Nieuwerburgh F, De Cuypere G, T'Sjoen G. Prevalence of Gender Nonconformity in Flanders, Belgium. Arch Sex Behav. 2015 Jul;44(5):1281-7. doi: 10.1007/s10508-014-0452-6. Epub 2015 Jan 15.
- Background: PubMed 28075632Meerwijk EL, Sevelius JM. Transgender Population Size in the United States: a Meta-Regression of Population-Based Probability Samples. Am J Public Health. 2017 Feb;107(2):e1-e8. doi: 10.2105/AJPH.2016.303578.
- Background: PubMed 28207334Meyer IH, Brown TN, Herman JL, Reisner SL, Bockting WO. Demographic Characteristics and Health Status of Transgender Adults in Select US Regions: Behavioral Risk Factor Surveillance System, 2014. Am J Public Health. 2017 Apr;107(4):582-589. doi: 10.2105/AJPH.2016.303648. Epub 2017 Feb 16.
- Background: PubMed 17188846De Cuypere G, Van Hemelrijck M, Michel A, Carael B, Heylens G, Rubens R, Hoebeke P, Monstrey S. Prevalence and demography of transsexualism in Belgium. Eur Psychiatry. 2007 Apr;22(3):137-41. doi: 10.1016/j.eurpsy.2006.10.002. Epub 2006 Dec 26.
- Pfizer Inc. Depo®-Testosterone (testosterone cypionate injection, USP0 \[package insert\]. U.S. Food and Drug Administration website.Link provided by the sponsor.
- Individual participant dataSharing planned: No. We will not be sharing individual participant data (IPD).
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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.
Antoni Duleba, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution in people with Transgenderism and Reproductive Issues, run by University of California, San Diego 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Antoni Duleba, MD (619-804-4765, aduleba@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Luteal Activity (ELA) (time frame: Through study completion, an average of 7 months.). The study lists 3 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 NCT07092527, which also lists 35 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 15 Jan 2026.