Actively Recruiting

Phase 4
Age: 18Years - 35Years
FEMALE
Healthy Volunteers
ID07092527

Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

Led by University of California, San Diego · Updated on 2026-01-15

80

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

Sponsors

U

University of California, San Diego

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of male-level testosterone on the reproductive hormone system in healthy females without polycystic ovary syndrome. The study focuses on transgender men beginning testosterone replacement therapy (TRT) and compares them to cisgender females with regular menstrual cycles. The goal is to understand how testosterone impacts ovarian hormones, pituitary hormone release, and menstrual patterns, addressing a gap in knowledge about menstrual changes during TRT. Participants include transgender men or non-binary individuals starting weekly testosterone injections for gender-affirming care, and a control group of cisgender females who do not receive treatment. The study tracks hormone levels and reproductive function over about seven months, with clinical and ultrasound evaluations performed periodically to monitor changes. During the study, participants will undergo blood tests to measure reproductive hormones like luteinizing hormone, follicle-stimulating hormone, estradiol, and testosterone. Uterine bleeding patterns and hormone secretion patterns will be closely observed. The research team will also perform ultrasound scans and clinical assessments to track reproductive health. The total participation lasts around seven months, during which hormone activity and menstrual changes are carefully evaluated.

CONDITIONS

Brief Title

Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

Who Can Participate

Age: 18Years - 35Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form
  • Willingness to comply with all study procedures and availability for the study duration
  • Age between 18 and 35 years
  • For transgender/non-binary group: planning to start testosterone therapy and history of regular menstrual cycles every 24-35 days before therapy
  • For cisgender female group: regular menstrual cycles every 24-35 days
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding within two months prior to enrollment
  • Incarcerated or institutionalized with known cognitive impairment
  • Hemoglobin less than 11 gm/dl at screening
  • Weight less than 110 pounds
  • Body mass index less than 18 or greater than 35
  • Current endocrine diseases such as untreated thyroid problems, pituitary or adrenal disease, polycystic ovary syndrome, or androgen-producing tumors
  • Recent pregnancy within two months prior to enrollment
  • Diabetes or kidney, liver, or heart disease
  • History of oophorectomy or hysterectomy
  • History of radiation or surgery involving brain or pelvic organs
  • Current use of medications affecting reproductive hormones, including contraceptives, androgens, estrogens, progestins, GnRH antagonists, insulinomimetics, or metformin
  • Prior use of testosterone therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 7 months

Participants in the transgender men group receive weekly testosterone injections as part of gender-affirming care. Cisgender female participants do not receive treatment but are observed as a control group.

Weekly visits for up to 7 months

Monitoring

Duration - Approximately 7 months

Participants undergo periodic clinical and ultrasonographic evaluations to study reproductive hormone secretion and menstrual patterns during the study.

Periodic visits during the treatment period

Trial Site Locations

Total: 1 location

1

University of California, San Diego

San Diego, California, United States, 92037

Actively Recruiting

Loading map...

Research Team

A

Antoni Duleba, MD

M

Marisa Hildebrand, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Similar Trials

A Novel Integrative Non-invasive Embryo Selection Approach f...

Reproductive Issues

Actively Recruiting

1 location

Development and Validation of an Artificial Intelligence Pla...

Infertility (IVF Patients)

Actively Recruiting

5 locations

Investigation of the Effects of Testosterone and Estrogen on...

Transsexualism

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline.

Wylie C Hembree, Peggy T Cohen-Kettenis, Louis Gooren...

https://pubmed.ncbi.nlm.nih.gov/28945902

Serum Testosterone Concentrations Remain Stable Between Injections in Patients Receiving Subcutaneous Testosterone.

Julie McFarland, Wendy Craig, Nigel J Clarke...

https://pubmed.ncbi.nlm.nih.gov/29264562

Dose-response analysis of testosterone replacement therapy in patients with female to male gender identity disorder.

Aya Nakamura, Masami Watanabe, Morito Sugimoto...

https://pubmed.ncbi.nlm.nih.gov/23117148

The health and well-being of transgender high school students: results from the New Zealand adolescent health survey (Youth'12).

Terryann C Clark, Mathijs F G Lucassen, Pat Bullen...

https://pubmed.ncbi.nlm.nih.gov/24438852