Androgen Effects on the Reproductive Neuroendocrine Axis

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Androgen Effects on the Reproductive Neuroendocrine Axis," is exploring how male hormones (androgens) affect the reproductive system in healthy females. The study aims to understand if taking male-level androgens can interfere with the body's hormonal signals related to reproduction. It is currently recruiting participants, specifically focusing on young women aged 18 to 35 who have regular menstrual cycles and are either planning to start testosterone therapy or are cisgender females with similar characteristics.

To be eligible for the trial, participants must provide consent and be willing to follow the study's procedures. However, certain individuals cannot participate, including those who are pregnant, have specific health conditions, or are currently using hormonal medications that could affect the study's results. Participants will have the opportunity to contribute to important research that could improve understanding of hormonal treatments for transgender and non-binary individuals, while also ensuring their health and safety throughout the process.

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, GnRH antagonists, GnRH agonists, insulinomimetics, and metformin.
• • History of prior testosterone therapy