Estrogen vs Moisturizer for Vaginal Dryness in Breast Cancer Patients
(REVIVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares a hormone-releasing ring and a moisturizing cream for treating vaginal dryness in breast cancer patients. It focuses on post-menopausal women undergoing specific cancer treatments who suffer from vaginal dryness. The hormone ring works by adding estrogen locally, while the cream provides moisture without hormones.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you must not use any additional estrogen during the study. You can continue using non-estrogen lubricants.
Is the treatment for vaginal dryness in breast cancer patients safe?
Research shows that both nonhormonal moisturizers like Replens and low-dose estrogen treatments have been found to be safe for treating vaginal dryness. Studies indicate that these treatments are well-tolerated, with low systemic absorption of estrogen, meaning they don't significantly affect the rest of the body.12345
How does the treatment for vaginal dryness in breast cancer patients differ from other options?
The treatment using ESTRING and Replens is unique because it offers both hormonal and non-hormonal options for managing vaginal dryness. ESTRING provides localized estrogen therapy, which can be effective but may not be suitable for all breast cancer patients due to potential hormone sensitivity. Replens, on the other hand, is a non-hormonal moisturizer that can be a safe alternative for those who wish to avoid hormones, although its effects may be more temporary.23678
What data supports the effectiveness of the treatment for vaginal dryness in breast cancer patients?
Research shows that both local estrogen therapy and non-hormonal vaginal moisturizers like Replens can effectively increase vaginal moisture and improve symptoms of vaginal dryness. However, while estrogen treatments provide more sustained benefits, non-hormonal moisturizers may only offer temporary relief.12367
Who Is on the Research Team?
Polly Niravath, MD
Principal Investigator
Houston Methodist Cancer Center
Are You a Good Fit for This Trial?
This trial is for post-menopausal women aged 18 or older with stage I-III ER+ breast cancer, currently on adjuvant AI therapy, and suffering from vaginal dryness or related symptoms since starting the therapy. Participants must not use additional estrogen during the study and should have no current vaginal infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either vaginal estrogen or Replens for the treatment of atrophic vaginitis
Follow-up
Participants are monitored for compliance with aromatase inhibitor therapy and changes in serum estrogen levels
Long-term follow-up
Evaluation of breast cancer recurrence and vaginal dryness by vaginal pH
What Are the Treatments Tested in This Trial?
Interventions
- ESTRING
- Replens
ESTRING is already approved in United States, European Union, Canada for the following indications:
- Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
- Vaginal dryness, itching, and burning caused by low estrogen levels or menopause
- Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
Find a Clinic Near You
Who Is Running the Clinical Trial?
Polly A. Niravath, MD
Lead Sponsor