REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
Exclusion Criteria:
- use of any exogenous estrogen within the preceding four weeks
- current vaginal infection.
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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