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

Running, not enrolling · Phase 2

Conditions studied: Estrogen Receptor Positive Breast Cancer, Breast Cancer

In brief

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.

Key facts

Study ID

NCT01984138

Run by

Polly A. Niravath, MD

People needed

33

Starts

2013-09-01

Expected to finish

2026-06-01

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• be female
• be 18 years of age or older.
• have stage I-III ER+ breast cancer
• be post-menopausal as defined by any of the following: age >55 years, history of bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or serum estradiol and FSH concentrations in the post-menopausal range along with either amenorrhea for 6 months or previous hysterectomy.
• currently take adjuvant AI therapy
• have vaginal dryness, dyspareunia, or ≥3 urinary tract infections per year since starting AI therapy
• Patients must agree not to use any additional estrogen during the five year study period. However, use of non-estrogen containing lubricants prior to sexual intercourse, or otherwise, is allowed.

You may not qualify if…

• use of any exogenous estrogen within the preceding four weeks
• current vaginal infection.

Where it is running

• Houston Methodist Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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