Investigating how testosterone affects reproductive hormones in transgender men
Official title: Androgen Effects on the Reproductive Neuroendocrine Axis
Run by University of California, San Diego · NCT06450405 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing how testosterone therapy affects hormone levels and menstrual cycles in transgender men compared to cisgender women with regular cycles.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 35 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06450405 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include transgender or non-binary individuals aged 18-35 who are planning to initiate testosterone therapy and have a history of regular menstrual cycles.
✕Probably not a fit
Patients who are pregnant, incarcerated, or have certain endocrine diseases or cognitive impairments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research examines the impact of testosterone replacement therapy (TRT) on the reproductive neuroendocrine axis in transgender men who are initiating testosterone therapy. The study will compare hormone levels and menstrual cycle regularity in transgender men before and during TRT with those of cisgender females who have regular menstrual cycles. Blood samples will be collected to assess reproductive hormone secretion, and participants will undergo clinical evaluations and ultrasounds throughout the study. The goal is to understand the mechanisms behind menstrual irregularities observed in transgender men receiving TRT.
Why it matters
Potential benefit: If successful, this study could provide insights into the hormonal effects of testosterone therapy, potentially improving care for transgender men.
How similar studies have gone: Other studies have explored hormonal therapies in transgender populations, but this specific investigation into the reproductive neuroendocrine axis with a focus on testosterone's effects is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of California San Diego
San Diego, California, United States Recruiting
Study contacts
- Principal investigator: Antoni Duleba, MD — UC San Diego
- Study coordinator: Antoni Duleba, MD
- Email: aduleba@health.ucsd.edu
- Phone: 619-804-4765
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.