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Estrogen
Estrogen vs Moisturizer for Vaginal Dryness in Breast Cancer Patients (REVIVE Trial)
Phase 2
Recruiting
Led By Polly Niravath, MD
Research Sponsored by Polly A. Niravath, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years
Awards & highlights
REVIVE Trial Summary
This triallooks into whether treatments like estrogen & moisturizers can help breast cancer patients with vaginal dryness during anti-estrogen treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
The REVIVE study compares two treatments for vaginal dryness in breast cancer patients on anti-estrogen treatment: a vaginal estrogen product called ESTRING and a non-hormonal moisturizer known as Replens.See study design
What are the potential side effects?
Potential side effects of ESTRING may include local irritation, discharge, or infection. Replens could cause similar local discomfort or reactions. Since these are topical treatments, systemic side effects are less common.
REVIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
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I am 18 years old or older.
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I have been diagnosed with early-stage, estrogen-receptor positive breast cancer.
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I am currently on hormone therapy for my cancer.
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I have had vaginal dryness, painful intercourse, or more than 3 UTIs a year since starting AI therapy.
REVIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
What is the number of participants that show improvement of symptoms using vaginal estrogen as compared to the control.
Secondary outcome measures
Compliance of use of Aromatase Inhibitor to assure safety
Other outcome measures
EXPLORATORY OBJECTIVE
Evaluation of vaginal dryness by vaginal pH
REVIVE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EstringExperimental Treatment1 Intervention
ESTRING
Group II: REPLENSActive Control1 Intervention
Replens
Find a Location
Who is running the clinical trial?
Polly A. Niravath, MDLead Sponsor
1 Previous Clinical Trials
37 Total Patients Enrolled
Polly Niravath, MDPrincipal InvestigatorHouston Methodist Cancer Center
1 Previous Clinical Trials
1 Trials studying Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a current vaginal infection.I have not used any estrogen products in the last 4 weeks.I have been diagnosed with early-stage, estrogen-receptor positive breast cancer.I am post-menopausal based on age, surgery, or hormone levels.I agree not to use any estrogen products for five years.I am female.I am 18 years old or older.I am currently on hormone therapy for my cancer.I have had vaginal dryness, painful intercourse, or more than 3 UTIs a year since starting AI therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Estring
- Group 2: REPLENS
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What afflictions can be remedied by the usage of ESTRING?
"ESTRING is a popular therapy for those whose menstrual cycle has ceased in the past 6 months, as well as hypoestrogenism, menopausal vasomotor symptoms, and breast health."
Answered by AI
What risks have been associated with ESTRING usage?
"Our Power team concluded that ESTRING's safety is likely a 2 owing to the fact it has only been subject to Phase 2 trials, meaning there have been some reports of its security but no studies proving its effectiveness."
Answered by AI
Are there currently any available positions for this trial?
"Clinicaltrials.gov states that this investigation has been recruiting since September 1st 2013 and the details were most recently updated on November 18th 2022."
Answered by AI
How many participants have been included in this research project?
"Affirmative. Based on the information available on clinicaltrials.gov, this medical trial is actively seeking participants. It was first posted in September 2013 and its most recent update happened in November 2022; 44 patients need to be recruited from 1 site."
Answered by AI
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