Postpartum Vaginal Estrogen

Sponsor
University Hospitals Cleveland Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05457972
Collaborator
(none)
100
1
2
12
8.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 four 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?

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 12-week study questionnaire will include the FSFI, the GAD-7 anxiety questionnaire, the Edinburgh Postnatal Depression Scale (EPDS), and the urinary distress inventory (UDI-6) 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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will 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.Patients will 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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

    Replens vaginal moisturizer, daily for two weeks then twice weekly for ten weeks.

    Device: Vaginal Moisturizer
    Replens has been cleared by the FDA as a personal lubricant for vaginal application.
    Other Names:
  • Replens Long-Lasting Vaginal Moisturizer
  • Outcome Measures

    Primary Outcome Measures

    1. Total FSFI score [12 weeks into study period]

      Female Sexual Function Index (FSFI) overall score

    Secondary Outcome Measures

    1. Desire as measured by FSFI [12 weeks into study period]

      One out of six FSFI domains

    2. Arousal as measured by FSFI [12 weeks into study period]

      One out of six FSFI domains

    3. Lubrication as measured by FSFI [12 weeks into study period]

      One out of six FSFI domains

    4. Orgasm as measured by FSFI [12 weeks into study period]

      One out of six FSFI domains

    5. Satisfaction as measured by FSFI [12 weeks into study period]

      One out of six FSFI domains

    6. Pain as measured by FSFI [12 weeks into study period]

      One out of six FSFI domains

    7. Intercourse resumption [12 weeks into study period]

      Number of weeks until resumption of intercourse after delivery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age 18 or older

    • Sexually active

    • Singleton, term (37 weeks 0 days) birth

    • Planning to breastfeed or pump during the study period

    • Ability to consent in English

    • 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)

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106

    Sponsors and Collaborators

    • University Hospitals Cleveland Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rachel Pope, Clinical Instructor, Obstetrics and Gynecology - CWRU School of Medicine, University Hospitals Cleveland Medical Center
    ClinicalTrials.gov Identifier:
    NCT05457972
    Other Study ID Numbers:
    • STUDY20220578
    First Posted:
    Jul 14, 2022
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Rachel Pope, Clinical Instructor, Obstetrics and Gynecology - CWRU School of Medicine, University Hospitals Cleveland Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2022