Clinical trial

Androgen Effects on the Reproductive Neuroendocrine Axis

Name

808679

Description

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

Trial arms

Trial start

2024-06-01

Estimated PCD

2028-06-01

Trial end

2029-06-01

Status

Not yet recruiting

Treatment

Testosterone Cypionate 50 MG/ML Injectable Solution

Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care. Participants in the discontinuing group will receive testosterone during their first month of enrollment and then will cease receiving testosterone. Participants in the discontinuing group will receive testosterone during their first month of enrollment and then will cease receiving testosterone.

Arms:

TGM discontinuing TRT, TGM initiating TRT

Other names:

Testosterone Replacement Therapy

Size

Primary endpoint

Evidence of Luteal Activity (ELA)

Through study completion, an average of 7 months.

Determination of pulsatile LH secretion

Through study completion, an average of 7 months.

Uterine bleeding pattern.

Through study completion, an average of 7 months.

Eligibility criteria

Inclusion Criteria: All 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Aged 18-35 Transgender/Non-binary Group - Initiators 4. Plan to initiate testosterone therapy 5. History of regular menstrual cycles (every 24-35 days) at baseline, before beginning TRT Transgender/Non-binary Group - Discontinuers 4. Plan to discontinue testosterone therapy 5. History of regular menstrual cycles (every 24-35 days) before beginning TRT Cisgender Female Group 4. Having regular menstrual cycles (every 24-35 days) Exclusion Criteria: All 1. Pregnant 2. Incarcerated 3. Known cognitive impairment or institutionalized 4. Hemoglobin less than 11 gm/dl at screening evaluation 5. Weight less than 110 pounds 6. BMI \<18 or \>35 7. Current endocrine disease- including untreated thyroid abnormalities, pituitary or adrenal disease, polycystic ovary syndrome, or androgen producing tumor 8. Current or recent pregnancy within two months of study enrollment 9. Current or recent breast feeding within two months of study enrollment 10. Diabetes, or renal, liver, or heart disease 11. History of oophorectomy or hysterectomy 12. History of radiation or surgery involving brain structures 13. Currently taking any medications that may affect their reproductive hormones, such as contraceptive medications, androgens, estrogens, progestins, GnRH antagonists, GnRH agonists, insulinomimetics, and metformin. For TRT Initiation Group and Cisgender Female group: 14. History of prior testosterone therapy

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine Blood serum'}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-06-10

1 organization

1 product

2 indications

Organization

University of California, San Diego

Product

Testosterone Cypionate

Indication

Gender Dysphoria

Indication

Reproductive Issues