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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD111650-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT) | Active Comparator | Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy |
|
| Cisgender Female (CGF) control group | No Intervention | Cisgender females serving as a control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution | Drug | Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through study completion, an average of 7 months. |
| Uterine Bleeding Pattern | All subjects will complete a daily uterine bleeding log using REDCap® | Through study completion, an average of 7 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Serum FSH | Measurement of serum follicle-stimulating hormone (FSH) levels | Through study completion, an average of 7 months. |
| Evaluate Serum AMH | Measurement of serum anti-mullerian hormone (AMH) levels |
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Inclusion Criteria: Transgender/Non-binary Group, Initiating Testosterone Group
Inclusion Criteria: Cisgender Female Group
Exclusion Criteria: All
Cisgender females; Transgender males/non-binary/gender non-conforming initiating testosterone replacement therapy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoni Duleba, MD | Contact | 619-804-4765 | aduleba@health.ucsd.edu | |
| Marisa Hildebrand, MPH | Contact | 619-804-4765 | mchildeb@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antoni Duleba, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | San Diego | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36238954 | Background | 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. | |
| Label | URL |
|---|---|
| Pfizer Inc. Depo®-Testosterone (testosterone cypionate injection, USP0 \[package insert\]. U.S. Food and Drug Administration website. | View source |
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We will not be sharing individual participant data (IPD).
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| ID | Term |
|---|---|
| D014189 | Transsexualism |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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|
| Through study completion, an average of 7 months. |
| Evaluate Serum LH | Measurement of serum luteinizing hormone (LH) levels | Through study completion, an average of 7 months. |
| Evaluate Serum Estradiol | Measurement of serum estradiol levels | Through study completion, an average of 7 months. |
| Evaluate Serum Testosterone | Measurement of serum testosterone levels | Through study completion, an average of 7 months. |
| 28945902 |
| Background |
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| Background | Pfizer Inc. Depo®-Testosterone (testosterone cypionate injection, USP0 [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085635s029lbl.pdf. Accessed May 30, 2022. |