Using vaginal estrogen to improve sexual function in breastfeeding patients after childbirth
Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial
This study tests if using vaginal estrogen cream can help breastfeeding women improve their sexual function after giving birth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05457972 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of vaginal estrogen cream on sexual function in postpartum patients who are breastfeeding. It is a prospective, randomized study conducted at University Hospitals MacDonald Women's Hospital, where eligible participants will be randomly assigned to receive either vaginal estrogen or a vaginal moisturizer. Participants will be evaluated for inclusion based on their medical records and will complete a baseline questionnaire before randomization. The study aims to determine if vaginal estrogen can alleviate sexual dysfunction commonly experienced during the postpartum period.
Who should consider this trial
Good fit: Ideal candidates are sexually active postpartum individuals aged 18 or older who are planning to breastfeed or pump and are between 6 weeks and 6 months postpartum.
Not a fit: Patients who have contraindications to estrogen therapy or a history of breastfeeding difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sexual function and quality of life for breastfeeding patients experiencing postpartum sexual dysfunction.
How similar studies have performed: Other studies have shown promising results with the use of vaginal estrogen for similar conditions, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Pope, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Susan D Wherley, MD
- Email: susan.wherley@uhhospitals.org
- Phone: 216-844-1446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.