Summary

Eligibility
for females ages 18-35 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by Antoni Duleba, MD
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 urinary and 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. Furthermore, the investigators will monitor menstrual cycles and reproductive hormones in TGM who make the personal decision to discontinue TRT, whether it is to pursue fertility or for other reasons.

Keywords

Transgenderism, Reproductive Issues, Methyltestosterone, Testosterone, Testosterone undecanoate, Testosterone enanthate, Testosterone 17 beta-cypionate, Testosterone Cypionate 50 MG/ML Injectable Solution, TGM initiating TRT, TGM discontinuing TRT

Eligibility

You can join if…

Open to females ages 18-35

All

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Aged 18-35

    Transgender/Non-binary Group - Initiators

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

Transgender/Non-binary Group - Discontinuers 4. Plan to discontinue testosterone therapy 5. History of regular menstrual cycles (every 24-35 days) before beginning TRT

Cisgender Female Group 4. Having regular menstrual cycles (every 24-35 days)

You CAN'T join if...

All

  1. Pregnant
  2. Incarcerated
  3. Known cognitive impairment or institutionalized
  4. Hemoglobin less than 11 gm/dl at screening evaluation
  5. Weight less than 110 pounds
  6. BMI <18 or >35
  7. Current endocrine disease- including untreated thyroid abnormalities, pituitary or adrenal disease, polycystic ovary syndrome, or androgen producing tumor
  8. Current or recent pregnancy within two months of study enrollment
  9. Current or recent breast feeding within two months of study enrollment
  10. Diabetes, or renal, liver, or heart disease
  11. History of oophorectomy or hysterectomy
  12. History of radiation or surgery involving brain structures
  13. Currently taking any medications that may affect their reproductive hormones, such as contraceptive medications, androgens, estrogens, progestins, GnRH antagonists, GnRH agonists, insulinomimetics, and metformin.

    For TRT Initiation Group and Cisgender Female group:

  14. History of prior testosterone therapy

Location

  • University of California San Diego
    San Diego California 92037 United States

Lead Scientist at UCSD

  • Antoni Duleba, MD
    Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 132 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
NCT06450405
Study Type
Observational
Participants
Expecting 80 study participants
Last Updated