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NCT04493333 · ClinicalTrials.gov registry record · Phase 2
Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors
A Phase 2 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04493333: Clinical Trial Phase 2 study, sponsored by University of Arkansas.
NCT04493333 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493333, a Phase 2 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone. By doing this study, the investigators hope to learn if Intrarosa® can improve vaginal discomfort. Participants will be assigned to one of two groups. One group will use Intrarosa® once a day. The other group will use Replens™ two times a week.
Primary Outcome
The change in the subject's calculated VMI from baseline to the end of treatment at 12 weeks (±1 week). VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is the same as VMI = %S + (0.5 x %I) when simplified. It has a potential range of 0-100. A VMI of 65-100 suggests a normal premenopausal environment, 50-64 indicates a moderate estrogenic effect, and \< 50 indicates atrophy.
Interventions
- DRUG Vaginal Dehydroepiandrosterone
- COMBINATION_PRODUCT Vaginal Polycarbophil Moisturizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2023-07-18 |
| Phase | Phase 2 |
Why NCT04493333 stopped before completion
NCT04493333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Vaginal Dehydroepiandrosterone is the first listed.
NCT04493333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04493333 about?
NCT04493333 is a clinical study titled "Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors". The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone. By doing this study, the investigators hope to learn if Intrarosa® can improve vaginal discomfort. Participants will be assigned to one of...
What is the current status of trial NCT04493333?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2021-06-07. Estimated completion is 2023-07-18.
What interventions are being tested in trial NCT04493333?
The interventions under investigation include: Vaginal Dehydroepiandrosterone (DRUG), Vaginal Polycarbophil Moisturizer (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04493333?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04493333's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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
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