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Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

NCT07092527 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-15

No results posted yet for this study

Summary

This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.

Conditions

  • Transgenderism
  • Reproductive Issues

Interventions

DRUG

Testosterone Cypionate 50 milligrams per millileter (mg/mL) Injectable Solution

Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of California, San Diego

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2028-11-15
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07092527 on ClinicalTrials.gov