Vaginal Estrogen Cream for Postpartum Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing whether applying estrogen cream inside the vagina can help women who have had severe tears during childbirth. These women often have problems like pain during sex and incontinence. The estrogen cream aims to improve tissue healing and reduce these symptoms.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is vaginal estrogen cream safe for humans?
How does the drug Estradiol 0.01% Vag Cream differ from other treatments for postpartum recovery?
Estradiol 0.01% Vag Cream is unique for postpartum recovery as it is a topical estrogen cream applied directly to the vaginal area, which may help with local tissue healing and hormone balance. Unlike other treatments that might be systemic or focus on different mechanisms, this cream specifically targets the vaginal tissues, potentially offering localized relief and recovery.678910
What data supports the effectiveness of the drug Estradiol 0.01% Vag Cream for postpartum recovery?
Who Is on the Research Team?
Hannah L Chapman, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for women aged 18 or older who have experienced severe tears during childbirth (3rd or 4th degree lacerations) and can apply vaginal cream themselves. It's not suitable for those with a history of blood clots, stroke, hormone-sensitive breast cancer, tobacco use, allergies to estradiol cream or its ingredients, or if they have an infection at the site of injury.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravaginal estrogen therapy or placebo starting at 2 weeks postpartum, continuing for 6 months
Follow-up
Participants are monitored for sexual function and incontinence symptom distress and impact
What Are the Treatments Tested in This Trial?
Interventions
- Estradiol 0.01% Vag Cream
- Placebo vaginal cream
Estradiol 0.01% Vag Cream is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor