This study is not yet accepting patients

Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

a study on Transgender Health Reproductive Issues

Summary

Eligibility
for females ages 18-35 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Antoni Duleba, MD (ucsd)
Headshot of Antoni Duleba
Antoni Duleba

Description

Summary

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

Details

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.

Keywords

Transgenderism, Reproductive Issues, Transsexualism, Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution, Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT)

Eligibility

You can join if…

Open to females ages 18-35

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)

You CAN'T join if...

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

Location

  • University of California, San Diego
    San Diego 5391811 California 5332921 92037 United States

Lead Scientist at University of California Health

  • Antoni Duleba, MD (ucsd)
    Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 134 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
Links
Pfizer Inc. Depo®-Testosterone (testosterone cypionate injection, USP0 [package insert]. U.S. Food and Drug Administration website.
ID
NCT07092527
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated