Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
Recruiting
Phase 4Interventional Study
TransgenderismReproductive Issues
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 35
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
80 (estimated)
Sponsor
University of California, San Diego · Other
Who this trial is looking for
This trial is looking for healthy young women and transgender individuals who are planning to start testosterone therapy. Participants will need to agree to study procedures and have a history of regular menstrual cycles.
Are You a Good Fit for This Trial?
Must not be takingContraceptivesAndrogensEstrogensProgestinsGnRH antagonistsInsulinomimetics
Rules you outCurrent endocrine diseasePolycystic ovary syndrome
You may be able to join if
I am aged 18-35
I have regular menstrual cycles
I plan to start testosterone therapy
I am willing to comply with all study procedures
I can provide signed consent
I am available for the duration of the study
You may not be able to join if
I am pregnant
I weigh less than 110 pounds
I have current diabetes or heart disease
I have a history of oophorectomy or hysterectomy
I have a known cognitive impairment
I am currently breastfeeding
I have had recent surgery involving my brain or pelvic area
I am taking medications that affect my reproductive hormones
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
Trial Locations
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Status
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
* Histor…
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, gonadotropin-releasing hormone (GnRH) antagonists, insulinomimetics, and metformin.
* History of prior testosterone therapy
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