RECRUITING

Postpartum Vaginal Estrogen for Breastfeeding Patients

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Conditions

BreastfeedingPostpartum Sexual DysfunctionVaginal Atrophypostpartumsexual dysfunctiondyspareuniapumpingvaginal dryness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-22
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05457972

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * Sexually active
  3. * Singleton, term (37 weeks 0 days) birth
  4. * Planning to breastfeed or pump during the study period
  5. * History of successful breastfeeding or pumping after a prior pregnancy
  6. * 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)
  7. * Ability to consent in English
  8. * Not meeting any exclusion criteria
  1. * Preterm delivery
  2. * Perinatal mortality
  3. * History of difficulty breastfeeding
  4. * 3rd or 4th degree perineal laceration
  5. * 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

Study Contact

Susan D Wherley, MD
CONTACT
216-844-1446
susan.wherley@uhhospitals.org
Rosemary Brewka
CONTACT
216-844-1446
rosemary.brewka@uhhospitals.org

Principal Investigator

Rachel Pope, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • Rachel Pope, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

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 Registration Dates

Study Start Date2025-02-22
Study Completion Date2025-10

Study Record Updates

Study Start Date2025-02-22
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breastfeeding
  • Postpartum Sexual Dysfunction
  • Vaginal Atrophy