Clinical trial NCT06450405: Androgen Effects on the Reproductive Neuroendocrine Axis
Official title: Androgen Effects on the Reproductive Neuroendocrine Axis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Transgenderism
Reproductive Issues
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-06-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: 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, GnRH antagonists, GnRH agonists, insulinomimetics, and metformin.
* History of prior testosterone therapy

Primary outcomes:
measure: Evidence of Luteal Activity (ELA)
timeFrame: Through study completion, an average of 7 months.
measure: Determination of pulsatile LH secretion
timeFrame: Through study completion, an average of 7 months.
measure: Uterine bleeding pattern.
timeFrame: Through study completion, an average of 7 months.
Secondary outcomes:
measure: Evaluate serum reproductive hormones
timeFrame: Through study completion, an average of 7 months.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UC San Diego
name: Antoni Duleba, MD
role: PRINCIPAL_INVESTIGATOR
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