Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04534881 · ClinicalTrials.gov registry record · Phase 2
Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen
A Phase 2 study, sponsored by St. Louis University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04534881: Clinical Trial Phase 2 study, sponsored by St. Louis University.
NCT04534881 is a Phase 2 study that was terminated before completion, run by St. Louis University. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534881, a Phase 2 study, was terminated before completion, sponsored by St. Louis University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Change from baseline till 24 weeks in serum testosterone concentrations between progesterone and placebo groups. Calculated as testosterone levels at 24 weeks minus baseline
Interventions
- DRUG Placebo
- DRUG Progesterone 200 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2023-01-18 |
| Phase | Phase 2 |
Why NCT04534881 stopped before completion
NCT04534881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04534881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04534881 about?
NCT04534881 is a clinical study titled "Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen". * 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 w...
What is the current status of trial NCT04534881?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2020-10-20. Estimated completion is 2023-01-18.
What interventions are being tested in trial NCT04534881?
The interventions under investigation include: Placebo (DRUG), Progesterone 200 MG (DRUG).
Who is sponsoring clinical trial NCT04534881?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04534881's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI