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Estrogen

Vaginal Estrogen for Sexual Dysfunction in Breastfeeding Patients

Phase 4
Waitlist Available
Led By Rachel Pope, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks into study period
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial found that using vaginal estrogen cream while breastfeeding does not improve sexual function for postpartum patients.

Who is the study for?
This trial is for postpartum individuals who are at least 18 years old, sexually active, have had a term birth, and plan to breastfeed or pump. They should be between 6 weeks and 6 months postpartum and able to consent in English. Those with preterm delivery, breastfeeding difficulties, estrogen contraindications like cancer or clotting disorders, severe perineal tears, or liver disease cannot join.
What is being tested?
The study tests if vaginal estrogen cream improves sexual function in postpartum patients who breastfeed compared to those using no treatment. Participants will either receive the estradiol cream or a non-medicated vaginal moisturizer to see which is more effective.
What are the potential side effects?
Vaginal estrogen may cause mild side effects such as local irritation or discharge. Systemic side effects are rare but can include changes in mood or skin condition due to hormone absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks into study period
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks into study period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total Female Sexual Function Index (FSFI) score
Secondary study objectives
Arousal as measured by Female Sexual Function Index (FSFI)
Desire as measured by Female Sexual Function Index (FSFI)
Intercourse resumption
+4 more

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175
18%
Breast Tenderness
15%
Cramps
15%
Itchiness at patch site
12%
Headaches
9%
Nausea
6%
Acne
6%
Lower Back Pain
6%
Hot Flashes
6%
Menstrual Bleeding
6%
Bloating
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perimenopausal Women, Depressed
Perimenopausal Women, Non-depressed

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vaginal EstrogenExperimental Treatment1 Intervention
Estradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks.
Group II: Vaginal MoisturizerActive Control1 Intervention
Vaginal moisturizer, daily for two weeks then twice weekly for ten weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
FDA approved

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
324 Previous Clinical Trials
342,824 Total Patients Enrolled
Rachel Pope, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

Estradiol (Estrogen) Clinical Trial Eligibility Overview. Trial Name: NCT05457972 — Phase 4
Sexual Dysfunction Research Study Groups: Vaginal Estrogen, Vaginal Moisturizer
Sexual Dysfunction Clinical Trial 2023: Estradiol Highlights & Side Effects. Trial Name: NCT05457972 — Phase 4
Estradiol (Estrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05457972 — Phase 4
~67 spots leftby Aug 2025
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