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NCT03739983 · ClinicalTrials.gov registry record · Phase 2
Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03739983: Clinical Trial Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT03739983 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03739983, a Phase 2 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Breast cancer patients commonly take medications to reduce the risk of recurrence, including aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient adherence. Early discontinuation of AI therapy results in an increased risk of cancer recurrence and increased risk of breast cancer-related death. Common side effects include vaginal dryness and vulvovaginal atrophy leading to worsening sexual function. To increase AI adherence, the investigators will study a non-pharmaceutical Vaginal Renewal Program (VRP) aimed at stimulating nitric oxide production to consequently increase vaginal lubrication, and improve the symptoms of vulvovaginal atrophy.
Primary Outcome
The investigators expect the percentage of superficial vaginal cells to be greater at the post-intervention time point when compared to the pre-intervention time point. If the percentage of superficial vaginal cells is ≥ 4% following the intervention, then the response will be considered positive.
Interventions
- DEVICE Vaginal Renewal Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2020-03-10 |
| Phase | Phase 2 |
Why NCT03739983 stopped before completion
NCT03739983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Vaginal Renewal Program is the first listed.
NCT03739983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03739983 about?
NCT03739983 is a clinical study titled "Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention". Breast cancer patients commonly take medications to reduce the risk of recurrence, including aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient adherence. Early discontinuation of AI therapy results in an increased risk of cancer recurrence and increased risk of b...
What is the current status of trial NCT03739983?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2019-11-19. Estimated completion is 2020-03-10.
What interventions are being tested in trial NCT03739983?
The interventions under investigation include: Vaginal Renewal Program (DEVICE).
Who is sponsoring clinical trial NCT03739983?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03739983's enrollment target sits among peer trials
2 2001st 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
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