For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

Exclusion Criteria:


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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Estrogen Receptor Positive Breast Cancer,Breast Cancer

Age (in years)

18+

Phase

Phase 2

Participants needed

44

Est. Completion Date

Jul 31, 2024

Treatment type

Interventional


Sponsor

The Methodist Hospital Research Institute

ClinicalTrials.gov identifier

NCT01984138

Study number

Revive

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