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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

December 16, 2024

Study Completion Date

December 31, 2025

Conditions
Estrogen Receptor Positive Breast CancerBreast Cancer
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.

Trial Locations (1)

77030

Houston Methodist Cancer Center, Houston

All Listed Sponsors
lead

Polly A. Niravath, MD

OTHER