Hormone Secretion in Transgender Males
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|ClinicalTrials.gov Identifier: NCT04321551|
Recruitment Status : Not yet recruiting
First Posted : March 25, 2020
Last Update Posted : March 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Transgenderism Healthy||Drug: Recombinant follicle-stimulating hormone Drug: Estradiol Valerate Drug: Progesterone Injectable||Phase 4|
Thirteen transgender men (TGM) and 13 cisgender female (CGF) control subjects with congruent female gender identity and sex will be enrolled in the following studies.
i. Ovarian follicle responses to FSH stimulation All subjects in each study group will undergo assessment of follicle responsiveness to intravenous (i.v.) recombinant FSH (r-FSH) stimulation 150 IU based on our previously published studies. Prior to testosterone treatment in TGM, r-FSH stimulation will be performed in the early follicular phase (EFP) of the cycle to approximate basal serum estradiol levels observed in the testosterone-treated TGM. Blood samples will be obtained before, and at 12 and 24 hours following each i.v. r-FSH injection for measurements of gonadotropins and sex steroid hormones. Subsequent r-FSH stimulation will be conducted on a random day at three- and six- months after testosterone treatment as we expect testosterone-treated TGM to be anovulatory. Blood samples will be obtained before, and at 12 and 24 hours following each i.v. r-FSH injection for measurements of sex steroid hormones.
ii. Gonadotropin responses to steroid hormone feedback On the morning of study day 1 (t=0) of study each subject will have a blood sample drawn in the morning for baseline hormone determinations. Subsequently, an intramuscular (i.m.) injection of estradiol valerate, 5 mg, will be administered. On study day 2 (t=48 hr), each subject will be administered an i.m. injection of progesterone in oil, 50 mg. Blood samples will be obtained t=0, +24, +48, +60, and +72 hr for the assessment of gonadotropin and steroid hormone levels. Serum FSH and LH levels following steroid administration in TGM will be compared to those observed in untreated TGM and CGF.
All subjects in each study group will undergo the same intervention as described above. TGM subjects will be studied during the early follicular phase of the menstrual cycle before and after three and six months of testosterone therapy. Should amenorrhea occur during T50 therapy, then study will be performed on a random day within one week of the three- and six- month time points. Untreated CGF controls will be studied once during the early follicular phase of the menstrual cycle.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gonadotropin and Steroid Hormone Secretion in Transgender Males|
|Estimated Study Start Date :||January 1, 2022|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Provocative Hormonal Testing
Recombinant follicle stimulating hormone (r-FSH) will be administered intravenously one time at a dose of 150 IU during the early follicular phase of the first menstrual cycle after enrollment (Menstrual Cycle I).
Subjects will receive no intervention during Menstrual Cycle II (washout cycle).
During the early follicular phase of Menstrual Cycle III, subjects will receive an intramuscular (i.m.) injection of estradiol valerate 5 mg on study day 1, followed by an i.m. injection of progesterone in oil 50 mg on study day 2.
Drug: Recombinant follicle-stimulating hormone
Intravenous injection of recombinant follicle-stimulating hormone 150 IU, once.
Drug: Estradiol Valerate
Intramuscular injection of estradiol valerate 5 mg, once
Drug: Progesterone Injectable
Intramuscular injection of progesterone in oil 50 mg, once
Other Name: Progesterone in Oil
- Luteinizing Hormone (LH) Level [ Time Frame: Within 48 hours after administration of estradiol valerate and progesterone injectable ]Peak serum LH level
- Estradiol (E2) Level [ Time Frame: Within 24 hours after administration of recombinant follicle-stimulating hormone level ]Peak Serum E2 level
- Follicle Stimulating Hormone (FSH) Level [ Time Frame: Within 48 hours after administration of estradiol valerate and progesterone injectable ]Peak serum FSH level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321551
|Contact: Tracy N Harrison, MDfirstname.lastname@example.org|
|Contact: Eunice Tingzonemail@example.com|