TERMINATED

Androgen Effects on the Reproductive Neuroendocrine Axis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Androgen Effects on the Reproductive Neuroendocrine Axis

Quick Facts

Study Start:2025-02-26

Study Completion:2025-03-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06450405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Antoni Duleba, MD

PRINCIPAL_INVESTIGATOR

UC San Diego

Study Locations (Sites)

University of California San Diego

San Diego, California, 92037

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Antoni Duleba, MD, PRINCIPAL_INVESTIGATOR, UC San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-26

Study Completion Date2025-03-03

Study Record Updates

Study Start Date2025-02-26

Study Completion Date2025-03-03

Terms related to this study

Additional Relevant MeSH Terms

Transgenderism
Reproductive Issues