← Back to Search

Progesterone for Transgender Individuals

Phase 2
Waitlist Available
Led By Sandeep Singh Dhindsa Dhindsa, MD
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial is testing whether or not progesterone affects testosterone levels in transwomen who are already taking estradiol as part of their gender affirming treatment. Participation will last for six months, during which time participants will have to give blood and take a pill once daily. There are no known risks for taking progesterone, but it may have benefits like increasing fat mass and breast size, and decreasing masculine hair patterns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy: Testosterone
Secondary outcome measures
Breast size
Efficacy: mood
Efficacy: sleep
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: progesteroneActive Control1 Intervention
subjects on active drug (progesterone)
Group II: placeboPlacebo Group1 Intervention
subjects on placebo

Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,635 Total Patients Enrolled
Sandeep Singh Dhindsa Dhindsa, MDPrincipal InvestigatorSt. Louis University

Media Library

progesterone Clinical Trial Eligibility Overview. Trial Name: NCT04534881 — Phase 2
Transgender Research Study Groups: progesterone, placebo
Transgender Clinical Trial 2023: progesterone Highlights & Side Effects. Trial Name: NCT04534881 — Phase 2
progesterone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04534881 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this research initiative?

"Affirmative. The information hosted on clinicaltrials.gov suggests that this medical research study is actively recruiting its participants, with the first posting taking place on October 20th 2020 and last amendment occurring June 30th 2022. This trial requires enrolment of twenty individuals at a solitary site."

Answered by AI

Is this research project enlisting individuals aged seventy or above?

"This medical trial is only open to individuals aged between 18 and 65. On the other hand, 8 separate trials offer aid for minors while there are 14 studies specifically tailored to elderly patients."

Answered by AI

Are there any remaining spots for participation in this experimental trial?

"Clinicaltrials.gov attests that this experiment is actively enrolling participants, with the initial advertisement being posted on October 20th 2020 and the most recent update taking place June 30 2022."

Answered by AI

How is progesterone generally utilized to benefit patient health?

"Utilizing progesterone, medical professionals may be able to treat uterine hemorrhage, rectify hormonal imbalances, and reduce the risk of spontaneous preterm birth recurrence."

Answered by AI

To what extent can progesterone be detrimental to individuals?

"Our experts at Power have evaluated progesterone to be moderately safe, giving it a rating of 2. This is because clinical trials are only in Phase 2 and there exists some evidence for safety but none suggesting efficacy."

Answered by AI

For which demographic is this clinical trial most suitable?

"Individuals between 18 and 65 who identify as transgender are eligible for this trial. A maximum of 20 people may participate in the study."

Answered by AI

Have there been precedent studies that have investigated the efficacy of progesterone?

"Currently, there are 42 clinical trials exploring the use of progesterone with 8 studies in its final phase. Barcelona, Catalunya is home to a few of these experiments though overall there are 268 sites hosting progesterone research."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Illinois
How old are they?
18 - 65
What site did they apply to?
Saint Louis University
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Saint Louis University: < 48 hours
Average response time
  • < 2 Days
~3 spots leftby Dec 2024