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NCT01984138 · ClinicalTrials.gov registry record · Phase 2
REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy
A Phase 2 study of Breast Cancer and Estrogen Receptor-positive Breast Cancer, sponsored by Polly A. Niravath, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT01984138: Active Phase 2 study of Breast Cancer and Estrogen Receptor-positive Breast Cancer, sponsored by Polly A. Niravath, MD.
NCT01984138 is a Phase 2 study of Breast Cancer and Estrogen Receptor-positive Breast Cancer that is active but no longer recruiting, run by Polly A. Niravath, MD. The registered enrollment target is 33 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01984138, a Phase 2 study of Breast Cancer and Estrogen Receptor-positive Breast Cancer, is active but no longer recruiting, sponsored by Polly A. Niravath, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is investigating whether breast cancer patients who experience vaginal dryness while on anti-estrogen treatment could benefit from either vaginal estrogen or from a vaginal moisturizer called Replens.
Primary Outcome
To compare improvement of atrophic vaginitis signs and symptoms between women on the vaginal estrogen ring and those on Replens vaginal cream. 1.1 Administer a questionnaire at baseline, 4 weeks, 12 weeks, and 24 weeks to all patients which will assess vaginal dryness and vaginal itching. Over six months, we expect that patients who are receiving vaginal estrogen will have more improvement in atrophic vaginitis symptoms as compared to those women on Replens.
Conditions Studied
Interventions
- DRUG Vagifem
- DRUG ESTRING
- DRUG Replens
Study Locations (1)
Texas
- Houston Methodist Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-09 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What the registry record for NCT01984138 still lists
NCT01984138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Vagifem is the first listed.
NCT01984138 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01984138 about?
NCT01984138 is a clinical study titled "REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy". This study is investigating whether breast cancer patients who experience vaginal dryness while on anti-estrogen treatment could benefit from either vaginal estrogen or from a vaginal moisturizer called Replens.
What is the current status of trial NCT01984138?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2013-09. Estimated completion is 2026-06.
What conditions does trial NCT01984138 study?
This clinical trial studies the following conditions: Breast Cancer, Estrogen Receptor-positive Breast Cancer.
What interventions are being tested in trial NCT01984138?
The interventions under investigation include: Vagifem (DRUG), ESTRING (DRUG), Replens (DRUG).
Who is sponsoring clinical trial NCT01984138?
This trial is sponsored by Polly A. Niravath, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01984138 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01984138's enrollment target sits among peer trials
33 935th of 1224 higher than 285 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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