Recruiting

Vaginal Estrogen

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT05457972

Conditions

Breastfeeding

Postpartum Sexual Dysfunction

Vaginal Atrophy

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Estradiol

Vaginal Moisturizer

Study Details

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.

Conditions

Breastfeeding

Postpartum Sexual Dysfunction

Vaginal Atrophy

Study ID

NCT05457972

Start date

Feb 22, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Estradiol

Imvexxy is an FDA-approved drug produced by TherapeuticsMD.

Vaginal Moisturizer

Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Susan D Wherley, MD

216-844-1446susan.wherley@uhhospitals.org

Rosemary Brewka

216-844-1446rosemary.brewka@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Susan Wherley, MD

216-844-1446susan.wherley@uhhospitals.org

Rosemary Brewka

216-844-1446rosemary.brewka@uhhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • vaginal atrophy
  • postpartum
  • sexual dysfunction
  • dyspareunia
  • breastfeeding
  • pumping
  • vaginal dryness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-07-23.