Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version
Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jul 22, 2025
Trial Information
Current as of November 11, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how testosterone, a male hormone given from outside the body, affects the way the brain controls reproductive hormones in healthy women who do not have certain medical conditions like polycystic ovary syndrome (PCOS). The goal is to understand whether taking testosterone at male levels changes the natural hormone signals that regulate the menstrual cycle and fertility.
Women aged 18 to 35 who have regular menstrual cycles may be eligible to join. This includes transgender or non-binary individuals who plan to start testosterone therapy, as well as cisgender women who are not taking testosterone. Participants will need to agree to follow all study steps and be available for the entire duration. People who are pregnant, have certain health issues, or are taking medications that affect hormones cannot join. If you participate, you can expect to have regular check-ins and tests to monitor how testosterone influences your hormone system. This research may help improve care for people using testosterone therapy in the future.
Gender
FEMALE
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, gonadotropin-releasing hormone (GnRH) antagonists, insulinomimetics, and metformin.
- • History of prior testosterone therapy
About University Of California, San Diego
The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Diego, California, United States
Patients applied
Trial Officials
Antoni Duleba, MD
Principal Investigator
University of California, San Diego
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported