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Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen

NCT04534881 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-03-19

Study results available
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Summary

* Purpose. The purpose of this research is study the effect of progesterone therapy on testosterone levels in transwomen who are currently on gender affirming treatment with estradiol.
* Duration. It is expected that participation will last for 6 months (24 weeks).
* Study Procedures. Participants will be asked to sign an informed consent, complete a medical history, have a physical exam conducted, have a fasting blood sample taken and asked to take a study drug once daily.
* Risks. Some of the foreseeable risks or discomforts include temporary discomfort, bleeding, bruising and/or swelling in the arm from blood draw. There are no known direct risks with the use of Progesterone in Transwomen for gender affirming therapy.
* Benefits. Some of the possible benefits that may be expected include increase in fat mass, increase in breast size/fullness, decrease in masculine hair patterns.

Conditions

  • Transgender Persons

Interventions

DRUG

Progesterone 200 MG

Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.

DRUG

Placebo

Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Sandeep Singh Dhindsa Dhindsa, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2023-01-18
Completion
2023-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04534881 on ClinicalTrials.gov