Androgen Effects on the Reproductive Neuroendocrine Axis (NCT06450405) | Clinical Trial Compass
TerminatedPhase 4
Androgen Effects on the Reproductive Neuroendocrine Axis
Stopped: The study sponsor terminated the grant funding.
United States2 participantsStarted 2025-02-26
Plain-language summary
This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
Who can participate
Age range18 Years ā 35 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,ā¦
What they're measuring
1
Evidence of Luteal Activity (ELA)
Timeframe: Through study completion, an average of 7 months.
2
Determination of Pulsatile LH Secretion
Timeframe: Through study completion, an average of 7 months.
3
Uterine Bleeding Pattern.
Timeframe: Through study completion, an average of 7 months.