Postpartum Vaginal Estrogen for Breastfeeding Patients

March 6, 2026 updated by: University Hospitals Cleveland Medical Center

Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective, randomized clinical trial of postpartum breastfeeding patients. Postpartum patients at University Hospitals (UH) MacDonald Women's Hospital will be evaluated for inclusion/exclusion by review of their medical record by the study investigators prior to discharge home. The study will then be discussed with the eligible patients privately. If they agree to participate, informed consent will be obtained. At this time, contact information will be obtained for all consenting patients.

Between 5 and 6 weeks postpartum, all consented patients will be contacted via their preferred form of communication. Inclusion criteria and desire for continued study participation will be verified prior to randomization. A baseline REDCap questionnaire will be texted or emailed to confirmed study participants. UH REDCap is a HIPAA-certified, secure, web-based data storage platform for research studies.

The patient will then be randomized in a 1:1 ratio into two study groups: vaginal estrogen or vaginal moisturizer. Randomization will be performed using blocking with a block size of 10 and a 1:1 allocation ratio. The randomization sequence will be generated using a random number table.

After randomization, but not prior to 6 weeks postpartum, the investigational drug service courier service will deliver softgel inserts of vaginal estrogen to the homes of participants randomized to the estrogen arm. Study investigators will deliver vaginal moisturizer to the homes of participants randomized to the placebo arm. Study participants will be provided with an instructional handout including information about how and how often to use the inserts or the moisturizer. Participants will be instructed to start using the inserts or lubricant when they receive the delivery. This will be considered the start of the study period.

During the study period, participants will use either estrogen or vaginal moisturizer nightly for two weeks and then twice weekly for ten weeks. Each week during the study period, participants will receive a message via their preferred communication method with five questions:

  • Did you breastfeed or pump this week?
  • Were you sexually active this week?
  • If you were sexually active, did you have vaginal pain with sexual activity?
  • How many times this week did you use the vaginal insert?

  • Did you experience any change in your health this week?

    6 and 12 weeks into the study period, the patient will be contacted by their preferred communication method and requested to complete a questionnaire via UH REDCap.

The initial study questionnaire will include questions about demographics, gravidity and parity, prior deliveries (including mode of delivery, obstetric lacerations, and infant feeding), baseline sexual activity, prior pelvic surgery, chronic pain disorders, and plans for infant feeding. The 6 and 12-week study questionnaires will include the FSFI, the GAD-7 anxiety questionnaire, the Edinburgh Postnatal Depression Scale (EPDS), and the urinary distress inventory (UDI-6), the vaginal assessment scale (VAS), the Sexual Function Questionnaire Medical Impact Scale (SFQ-MIS), and the Female Sexual Distress Scale-Revised (FSDS-R) as well as questions about sexual activity and plans for infant feeding.

Questionnaire responses will be reviewed by a study investigator after completion by the patient. Any patients whose questionnaires indicate possible depression (EPDS score 10+), thoughts of self-harm (any answer other than "never" on EPDS question 10), or moderate to severe anxiety (GAD-7 score 10+) will be evaluated for safety by a physician study investigator and referred to UH Reproductive Behavioral Health.

In order to assess long term benefits of estrogen therapy in the early postpartum period, additional questionnaires will be administered at 6 months and 1 year to patients. The study intervention period will last 12 weeks, after which no additional vaginal estrogen or vaginal moisturizer will be administered to participants. Patients desiring to continue treatment after the 12-week study intervention period will be referred to their postpartum care provider. Patients will be instructed to stop estrogen use after they have completed breastfeeding.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 or older
  • Sexually active
  • Singleton, term (37 weeks 0 days) birth
  • Planning to breastfeed or pump during the study period
  • History of successful breastfeeding or pumping after a prior pregnancy
  • Between 6 weeks and 6 months postpartum (patients may be recruited at any time during the postpartum period, but the study period will not start until 6 weeks postpartum)
  • Ability to consent in English
  • Not meeting any exclusion criteria

Exclusion Criteria:

  • Preterm delivery
  • Perinatal mortality
  • History of difficulty breastfeeding
  • 3rd or 4th degree perineal laceration
  • Any contraindications to estrogen, including, but not limited to, breast cancer or a history of breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis (DVT)/pulmonary embolism (PE) or a history of these conditions, active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions, known anaphylactic reaction, angioedema, or hypersensitivity to estrogen, hepatic impairment or disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal Estrogen
Estradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks.
Drug: Estradiol
Imvexxy is an FDA-approved drug produced by TherapeuticsMD.
Other Names:
  • Imvexxy
Active Comparator: Vaginal Moisturizer
Vaginal moisturizer, daily for two weeks then twice weekly for ten weeks.
Device: Vaginal Moisturizer
Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).
Other Names:
  • Carlson Key-E Suppositories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Female Sexual Function Index (FSFI) score
Time Frame: Up to 12 weeks into study period
Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning. A score of 26 has been validated as a threshold for diagnosing female sexual dysfunction.
Up to 12 weeks into study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desire as measured by Female Sexual Function Index (FSFI)
Time Frame: Up to 12 weeks into study period
One out of six FSFI domains. Score range of 1.2-6, with a higher score indicating better functioning.
Up to 12 weeks into study period
Arousal as measured by Female Sexual Function Index (FSFI)
Time Frame: Up to 12 weeks into study period
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Up to 12 weeks into study period
Lubrication as measured by Female Sexual Function Index (FSFI)
Time Frame: Up to 12 weeks into study period
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Up to 12 weeks into study period
Orgasm as measured by Female Sexual Function Index (FSFI)
Time Frame: Up to 12 weeks into study period
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Up to 12 weeks into study period
Satisfaction as measured by Female Sexual Function Index (FSFI)
Time Frame: Up to 12 weeks into study period
One out of six FSFI domains. Score range of 0.8-6, with a higher score indicating better functioning.
Up to 12 weeks into study period
Pain as measured by Female Sexual Function Index (FSFI)
Time Frame: Up to 12 weeks into study period
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Up to 12 weeks into study period
Intercourse resumption
Time Frame: Up to 12 weeks into study period
Number of weeks until resumption of intercourse after delivery
Up to 12 weeks into study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Rachel Pope, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20220578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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