Active — Not RecruitingPhase 2

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

United States33 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

What is the number of participants that show improvement of symptoms using vaginal estrogen as compared to the control.

Timeframe: 4.5 years

Trial details

NCT IDNCT01984138

SponsorPolly A. Niravath, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-03

View on ClinicalTrials.gov More Estrogen Receptor Positive Breast Cancer trials