Postpartum Vaginal Estrogen for Breastfeeding Patients

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT05457972
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Breastfeeding
  • Postpartum Sexual Dysfunction
  • Vaginal Atrophy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Estradiol — DRUG
    Imvexxy is an FDA-approved drug produced by TherapeuticsMD.
  • Vaginal Moisturizer — DEVICE
    Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).

Study Details

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.

Key Dates

Start date
Feb 22, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vaginal Estrogen
    Estradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks.
  • Active Comparator: Vaginal Moisturizer
    Vaginal moisturizer, daily for two weeks then twice weekly for ten weeks.

Primary Outcome Measure

Total Female Sexual Function Index (FSFI) score [ Time Frame: Up to 12 weeks into study period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Susan Wherley, MD
[email protected]
216-844-1446
Rosemary Brewka
[email protected]
216-844-1446

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By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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