Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

Обзор

This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.

Подробное описание

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.

Вмешательства

• Препарат Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution
  Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.

Первичные конечные точки

• Evidence of Luteal Activity (ELA) [Срок оценки: Through study completion, an average of 7 months.]
• Determination of Pulsatile Luteinizing Hormone (LH) Secretion [Срок оценки: Through study completion, an average of 7 months.]
• Uterine Bleeding Pattern [Срок оценки: Through study completion, an average of 7 months.]

Вторичные конечные точки (5)

• Evaluate Serum FSH [Срок оценки: Through study completion, an average of 7 months.]
• Evaluate Serum AMH [Срок оценки: Through study completion, an average of 7 months.]
• Evaluate Serum LH [Срок оценки: Through study completion, an average of 7 months.]
• Evaluate Serum Estradiol [Срок оценки: Through study completion, an average of 7 months.]
• Evaluate Serum Testosterone [Срок оценки: Through study completion, an average of 7 months.]

Критерии участия

Inclusion Criteria: Transgender/Non-binary Group, Initiating Testosterone Group

• 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
• Plan to initiate testosterone therapy
• History of regular menstrual cycles (every 24-35 days) at baseline, before beginning TRT

Inclusion Criteria: Cisgender Female Group

• 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)

Exclusion Criteria: All

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of California, San Diego — San Diego

Публикации

• 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, PMID 36238954
• Hembree 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. PMID 28945902
• Deutsch 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. PMID 25730222
• McFarland 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. PMID 29264562
• Nakamura 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. PMID 23117148
• Conron 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. PMID 22095354
• Clark 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. PMID 24438852
• Kuyper 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. PMID 23857516

Идентификаторы

NCT: NCT07092527 · 813087 · 1R01HD111650-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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