Estradiol for Atrophy

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University Hospitals Cleveland Medical Center, Cleveland, OH
Atrophy+3 More
Estradiol - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

Sexual dysfunction is very common in the postpartum period and is more common in people who breastfeed or pump. This research study was designed to help determine whether postpartum patients who use vaginal estrogen cream while breastfeeding have improved sexual function compared to postpartum patients who do not.

Eligible Conditions

  • Atrophy
  • Breast Feeding
  • Atrophic
  • Postpartum Sexual Dysfunction

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 12 weeks into study period

Week 12
Arousal as measured by FSFI
Desire as measured by FSFI
Intercourse resumption
Lubrication as measured by FSFI
Orgasm as measured by FSFI
Pain as measured by FSFI
Satisfaction as measured by FSFI
Total FSFI score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Perimenopausal Women, Depressed
18%Breast Tenderness
15%Cramps
15%Itchiness at patch site
12%Headaches
9%Nausea
6%Acne
6%Hot Flashes
6%Lower Back Pain
6%Menstrual Bleeding
6%Bloating
3%Dizziness
0%Waking during the night
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02255175) in the Perimenopausal Women, Depressed ARM group. Side effects include: Breast Tenderness with 18%, Cramps with 15%, Itchiness at patch site with 15%, Headaches with 12%, Nausea with 9%.

Trial Design

2 Treatment Groups

Vaginal Moisturizer
1 of 2
Vaginal Estrogen
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Estradiol · No Placebo Group · Phase 4

Vaginal Estrogen
Drug
Experimental Group · 1 Intervention: Estradiol · Intervention Types: Drug
Vaginal Moisturizer
Device
ActiveComparator Group · 1 Intervention: Vaginal Moisturizer · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
2008
Completed Phase 4
~4350

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks into study period
Closest Location: University Hospitals Cleveland Medical Center · Cleveland, OH
Photo of university hospitals cleveland medical center 1Photo of university hospitals cleveland medical center 2Photo of university hospitals cleveland medical center 3
2011First Recorded Clinical Trial
3 TrialsResearching Atrophy
172 CompletedClinical Trials

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
297 Previous Clinical Trials
336,204 Total Patients Enrolled
1 Trials studying Atrophy
250 Patients Enrolled for Atrophy
Rachel Pope, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are sexually active.
You are planning to breastfeed or pump during the study period.
You are between 6 weeks and 6 months postpartum.
You are a term (37 weeks 0 days) birth.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References