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Androgen Effects on the Reproductive Neuroendocrine Axis Study

This study is looking at how testosterone affects the reproductive system in transgender men (assigned female at birth, identify as male). Researchers want to understand why menstrual cycles change when people start gender-affirming testosterone therapy. You might be able to join if you are a woman between 18 and 35 years old, plan to start testosterone therapy, and have regular menstrual cycles. The study will measure things like signs of ovulation (Luteal Activity), how a hormone called Luteinizing Hormone (LH) is released, and your uterine bleeding patterns over about 7 months. The study plans to enroll 80 participants and is currently unclear about its recruitment status.

Study design
This is an interventional study planning to enroll 80 participants. It will involve participants receiving weekly doses of Testosterone Cypionate 50 milligrams per milliliter (mg/mL) Injectable Solution.
What's involved
You would need to agree to all study procedures and be available for the duration of the study, which averages 7 months. This includes blood tests and clinical and ultrasound evaluations.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, an average of 7 months, to measure primary endpoints.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07092527

Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

Recruiting
PHASE4Ages 18–35InterventionalBasic science
University of California, San Diego
~80 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evidence of Luteal Activity (ELA)
Measured over Through study completion, an average of 7 months.
+2 more outcomes measured

Conditions

Transgenderism
Reproductive Issues

Explore related trials

Reproductive HistoryTransgenderism

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Antoni Duleba, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Antoni Duleba, MD
[email protected]
619-804-4765
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • Evidence of Luteal Activity (ELA)Through study completion, an average of 7 months.

    Evidence of Luteal Activity (ELA), as defined by serum progesterone level above 3 ng/mL in transgender men initiating testosterone replacement therapy.

  • Determination of Pulsatile Luteinizing Hormone (LH) SecretionThrough study completion, an average of 7 months.

    Subjects will have baseline measurement of serum LH immediately followed by frequent blood sampling at 10-min intervals for 8 h. We will measure LH pulse frequency, the number of LH pulses per 8 hours.

  • Uterine Bleeding PatternThrough study completion, an average of 7 months.

    All subjects will complete a daily uterine bleeding log using REDCap®