50 Participants Needed

Vaginal Estrogen Cream for Postpartum Recovery

HL
Overseen ByHannah L Chapman, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: University of Alabama at Birmingham
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that vaginal estrogen creams, like Vagifem and others, have been studied for safety in treating conditions like atrophic vaginitis (thinning and inflammation of the vaginal walls). These studies generally support their safety for human use.12345

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?

Research shows that estradiol vaginal cream is effective in relieving symptoms like vaginal dryness and itching in postmenopausal women, which suggests it may help with similar symptoms in postpartum recovery.1231112

Who Is on the Research Team?

HL

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

Women who have had severe tears during childbirth.
I can apply vaginal cream by myself.
I have experienced severe tearing during childbirth.

Exclusion Criteria

I cannot use intra-vaginal estrogen due to a history of DVT, stroke, or hormone-sensitive breast cancer.
I had complications with my perineal wound 2 weeks after giving birth.
You smoke or use tobacco products.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive intravaginal estrogen therapy or placebo starting at 2 weeks postpartum, continuing for 6 months

6 months
Initial visit at 2 weeks postpartum, followed by regular follow-ups

Follow-up

Participants are monitored for sexual function and incontinence symptom distress and impact

6 months
Follow-up visits at 12 weeks and 6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

  • Estradiol 0.01% Vag Cream
  • Placebo vaginal cream
Trial Overview The study tests whether applying a topical vaginal estrogen cream (Estradiol 0.01%) after childbirth helps with recovery from obstetric anal sphincter injuries compared to a placebo cream. The focus is on improving sexual function and reducing distress from urinary and bowel incontinence.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Topical vaginal estrogen groupActive Control1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention

Estradiol 0.01% Vag Cream is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Estradiol 0.01% Vag Cream for:
🇪🇺
Approved in European Union as Vagifem for:
🇨🇦
Approved in Canada as Estrace for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Published Research Related to This Trial

Both 25-μg 17β-estradiol vaginal tablets and 1.25-mg conjugated equine estrogen vaginal cream effectively relieve symptoms of atrophic vaginitis in menopausal women, as shown in a study of 159 participants over 24 weeks.
The vaginal tablets resulted in fewer systemic side effects and lower rates of endometrial proliferation compared to the cream, along with higher patient satisfaction and lower withdrawal rates, indicating they may be a safer and more acceptable option.
17β-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis.Rioux, JE., Devlin, MC., Gelfand, MM., et al.[2022]
Both 25-microg 17beta-estradiol vaginal tablets and 1.25-mg conjugated equine estrogen vaginal cream effectively relieve symptoms of atrophic vaginitis in menopausal women, as shown in a study with 159 participants over 24 weeks.
The vaginal tablets were associated with fewer systemic side effects, lower rates of endometrial proliferation, and higher patient satisfaction, leading to a lower withdrawal rate compared to the vaginal cream.
17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis.Rioux, JE., Devlin, C., Gelfand, MM., et al.[2022]
In a study of 160 postmenopausal women, both Vagifem (an estradiol vaginal tablet) and vaginal estrogen cream effectively improved symptoms of atrophic vaginitis, showing no significant difference in treatment effectiveness.
Vagifem was associated with a significantly lower rate of hygienic issues (0% vs. 23%) and was reported as easier to use by 90% of patients compared to 55% for estrogen cream, making it a more user-friendly option.
A comparative study of vaginal estrogen cream and sustained-release estradiol vaginal tablet (Vagifem) in the treatment of atrophic vaginitis in Isfahan, Iran in 2010-2012.Hosseinzadeh, P., Ghahiri, A., Daneshmand, F., et al.[2020]

Citations

17β-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis. [2022]
17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis. [2022]
A comparative study of vaginal estrogen cream and sustained-release estradiol vaginal tablet (Vagifem) in the treatment of atrophic vaginitis in Isfahan, Iran in 2010-2012. [2020]
Safety and efficacy of micronized estradiol vaginal cream. [2019]
Efficacy of estradiol vaginal cream in postmenopausal women. [2019]
Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. [2015]
Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. [2022]
Cervical ripening before medical induction of labor: a comparison of prostaglandin E2, estradiol, and oxytocin. [2019]
Prostaglandin E2 gel In ripening of cervix in induction of labour. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
The sequential use of estradiol and prostaglandin E2 topical gels for cervical ripening in high-risk term pregnancies requiring induction of labor. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Prostaglandin metabolite levels during cervical ripening with a controlled-release hydrogel polymer prostaglandin E2 pessary. [2019]
Vaginal delivery following caesarean section-the use of oxytocin and prostaglandins. [2004]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security