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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Polly A. Niravath, MD; Polly Niravath
• Treatments: Aromatase Inhibitors; Calcium polycarbophil; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate; Psyllium

Criteria

Inclusion Criteria:

1. be female

2. be 18 years of age or older.

3. have stage I-III ER+ breast cancer

4. 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.

5. currently take adjuvant AI therapy

6. have vaginal dryness, dyspareunia, or ≥3 urinary tract infections per year since starting AI therapy

7. 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:

1. use of any exogenous estrogen within the preceding four weeks

2. current vaginal infection.