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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
Must not have
Current vaginal infection
Use of any exogenous estrogen within the preceding four weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
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.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a current vaginal infection.
Select...
I have not used any estrogen products in the last 4 weeks.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
What is the number of participants that show improvement of symptoms using vaginal estrogen as compared to the control.
Secondary study objectives
Compliance of use of Aromatase Inhibitor to assure safety
Other study objectives
EXPLORATORY OBJECTIVE
Evaluation of vaginal dryness by vaginal pH
Awards & Highlights
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EstringExperimental Treatment1 Intervention
ESTRING
Group II: REPLENSActive Control1 Intervention
Replens
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Endocrine therapies, such as tamoxifen and aromatase inhibitors, are pivotal in treating hormone receptor-positive breast cancer by blocking estrogen receptors or reducing estrogen production, thereby slowing tumor growth. Local estrogen therapy, like vaginal estrogen, specifically targets vaginal dryness caused by systemic anti-estrogen treatments without significantly raising systemic estrogen levels.
Replens, a non-hormonal moisturizer, alleviates vaginal dryness by hydrating and maintaining vaginal tissue health. These treatments are essential for improving the quality of life for breast cancer patients by addressing side effects that impact daily living.
Exploring the Molecular Mechanism of the Drug-Treated Breast Cancer Based on Gene Expression Microarray.Implementing neoadjuvant endocrine strategies in ER-positive, HER2-negative breast cancer.Adjuvant therapy of breast cancer: update.
Exploring the Molecular Mechanism of the Drug-Treated Breast Cancer Based on Gene Expression Microarray.Implementing neoadjuvant endocrine strategies in ER-positive, HER2-negative breast cancer.Adjuvant therapy of breast cancer: update.
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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
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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.
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