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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 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03739983
The ClinicalTrials.gov registry entry for NCT03739983 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vaginal Renewal Program is the first listed.
NCT03739983 reports 0 study locations.
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.
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