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REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy

NCT01984138 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-01-28

No results posted yet for this 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.

Conditions

Interventions

DRUG

ESTRING

ESTRING (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days. ESTRING has the following dimensions: outer diameter 55 mm; cross-sectional diameter 9 mm; core diameter 2 mm. One ESTRING should be inserted into the upper third of the vaginal vault, to be worn continuously for three months.

DRUG

Replens

Replens should be applied vaginally, with a supplied applicator, three times each week.

DRUG

Vagifem

VAGIFEM: Vagifem (estradiol vaginal tablet) is a small, white round, film-coated, bi-convex vaginal insert, which measures 6 mm. Each vaginal insert contains 10 mcg of estradiol, and it is administered via disposable applicator. The insert is placed vaginally using the applicator, and it will dissolve on its own while releasing estradiol into the local tissues

Sponsors & Collaborators

  • Polly A. Niravath, MD

    lead OTHER

Principal Investigators

  • Polly Niravath, MD · Houston Methodist Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2025-06-03
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01984138 on ClinicalTrials.gov