Hormone Secretion in Transgender Males

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Significant proportions of TGM report desired child-bearing and many engage in receptive vaginal intercourse with cisgender men or transgender women. Despite the frequency of desired fertility among TGM, secondary amenorrhea and associated infertility are common in those undergoing treatment with testosterone. Although testosterone is the mainstay of gender affirming care in this population, the mechanism of androgen-induced menstrual suppression is unknown due to the limited quantity of well-designed, clinical research investigating hypothalamic-pituitary-ovarian function in testosterone-treated TGM. We hypothesize that gender affirming testosterone therapy causes infertility in transgender men through impaired gonadotropin secretion, altered ovarian function, or a combination of these effects. We therefore propose to study the effect of high-dose, exogenous androgen administration on pituitary function, ovarian folliculogenesis, and ovulatory function in transgender men. Please note that administration of testosterone cyprionate, at a dose of 50 mg (T50) per week, will be done at Planned Parenthood of the Pacific Southwest by Dr. Kyle Bukowski. Who is the Associate Medical Director. In the first of our studies, in order to determine whether normal feedback mechanisms responsible for induction of gonadotropin responses to circulating steroid hormones are altered in TGM on testosterone, we will transiently administer steroid hormones and measure resultant changes in gonadotropin secretion among TGM before and during testosterone therapy, and in untreated cisgender female control subjects. In the next study, to determine whether testosterone alters ovarian follicle function and steroidogenesis, we will assess granulosa cell production of estradiol in response to FSH stimulation in TGM before and during testosterone therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Follicle Stimulating Hormone; Hormones; Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

• Cisgender Female or Transgender Male

• Regular menstrual cycles

• For self-identified transgender males, must plan to initiate testosterone therapy for the first time within 3 months of study enrollment

Exclusion Criteria:

• 1. Hemoglobin less than 11 gm/dl at screening evaluation

• Untreated thyroid abnormalities

• Current endocrine disease- including 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

• BMI > 35

• Diabetes, or renal, liver, or heart disease

• History of oophorectomy

• History of radiation or surgery involving brain structures

• Current hormonal medication use (including birth control pills and hormone replacement therapy)

• History of prior testosterone therapy