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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 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.

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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.

Interventions

  • DRUG Vagifem
  • DRUG ESTRING
  • DRUG Replens

Study Locations (1)

Texas

  • Houston Methodist Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2013-09
Est. Completion 2026-06
Phase Phase 2

Sponsor

Polly A. Niravath, MD

1 total trials

What the Registry Record Tells You About NCT01984138

The ClinicalTrials.gov registry entry for NCT01984138 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Polly A. Niravath, MD, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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