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Search / Trial NCT05457972

Postpartum Vaginal Estrogen for Breastfeeding Patients

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · Jul 11, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Vaginal Atrophy Postpartum Sexual Dysfunction Dyspareunia Breastfeeding Pumping Vaginal Dryness

ClinConnect Summary

This clinical trial is studying the effects of vaginal estrogen cream on sexual function in women who are breastfeeding after giving birth. Many new mothers experience sexual problems during this time, especially those who breastfeed or pump milk. The researchers want to find out if using vaginal estrogen can help improve these issues compared to mothers who do not use the cream.

To participate in this study, you need to be a woman aged 18 or older who is sexually active and planning to breastfeed or pump milk after giving birth. You should be between 6 weeks and 6 months postpartum, meaning you have had your baby within that time frame. Some women may not be eligible if they had a difficult delivery, a history of certain medical conditions, or issues with breastfeeding in the past. If you join the study, you’ll use the vaginal cream and report on your sexual health to help determine if it makes a difference. This research could provide valuable information for improving the well-being of breastfeeding mothers.

Gender

FEMALE

Eligibility criteria

  • 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.

About University Hospitals Cleveland Medical Center

University Hospitals Cleveland Medical Center is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with Case Western Reserve University, the center integrates cutting-edge medical education, comprehensive patient care, and pioneering clinical trials to enhance treatment options and improve patient outcomes. With a diverse range of specialized programs and a robust infrastructure for research, University Hospitals Cleveland Medical Center plays a vital role in translating scientific discoveries into effective therapies, ensuring access to the latest advancements in medicine for patients and communities.

Locations

Cleveland, Ohio, United States

Patients applied

1 patients applied

Trial Officials

Rachel Pope, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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