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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks into study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks into study period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Female Sexual Function Index (FSFI) score
Secondary outcome measures
Arousal as measured by Female Sexual Function Index (FSFI)
Desire as measured by Female Sexual Function Index (FSFI)
Intercourse resumption
+4 moreSide effects data
From 2018 Phase 4 trial • 64 Patients • NCT0225517518%
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
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
317 Previous Clinical Trials
340,157 Total Patients Enrolled
Rachel Pope, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had a severe tear in the perineal area.I am sexually active.I had a full-term, single baby birth.I do not have conditions that make estrogen unsafe for me, like certain cancers or clotting disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Vaginal Estrogen
- Group 2: Vaginal Moisturizer
Awards:
This trial has 5 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration endorsed Estradiol?
"The safety of Estradiol was rated at a 3, since the Phase 4 trial shows that this medication has been officially sanctioned."
Answered by AI
Are individuals currently being accepted into this experiment?
"The information on clinicaltrials.gov implies that this medical trial is not currently recruiting patients; however, it was initially posted on August 1st 2022 and modified as recently as July 11th 2022. Despite this particular study's lack of recruitment, there are 232 other trials which require participants at the moment."
Answered by AI
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