Androgen Effects on the Reproductive Neuroendocrine Axis
NCT ID: NCT06450405
Last Updated: 2025-07-22
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE4
Total Enrollment
2 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-02-26
Study Completion Date
2025-03-03
Brief Summary
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This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.
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Detailed Description
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Testosterone Replacement Therapy (TRT) is the mainstay of gender affirming care for transgender men (TGM) who have male gender identity after female sex assignment at birth. TGM receiving TRT over time exhibit irregular menstrual bleeding, however, the mechanism of menstrual disruption is unknown. Therefore, the investigators propose to evaluate the effect of chronic testosterone (T) exposure on ovarian hormones and pituitary gonadotropin release that determines menstrual cyclicity. The investigators will conduct a detailed study of blood reproductive hormone secretion in TGM before and during TRT as well as in untreated cisgender female (CGF) control subjects who report female gender identity congruent with female sex assignment at birth. The investigators will also perform periodic clinical and ultrasonographic evaluations.
Conditions
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Transgenderism
Reproductive Issues
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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TGM initiating TRT
Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy
Group Type
ACTIVE_COMPARATOR
Testosterone Cypionate 50 MG/ML Injectable Solution
Intervention Type
DRUG
Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.
CGF control group
Cisgender females serving as a control group
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Testosterone Cypionate 50 MG/ML Injectable Solution
Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.
Intervention Type
DRUG
Other Intervention Names
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Testosterone Replacement Therapy
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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 Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
35 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
University of California, San Diego
OTHER
Sponsor Role
lead
Responsible Party
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Antoni Duleba
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Antoni Duleba, MD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Locations
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University of California San Diego
San Diego, California, United States
Site Status
Countries
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United States
References
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BACKGROUND
Pfizer Inc. Depo®-Testosterone (testosterone cypionate injection, USP0 [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085635s029lbl.pdf. Accessed May 30, 2022.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085635s029lbl.pdf
Pfizer Inc. Depo®-Testosterone (testosterone cypionate injection, USP0 \[package insert\]. U.S. Food and Drug Administration website.
Other Identifiers
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808679
Identifier Type: -
Identifier Source: org_study_id
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