Vaginal Estrogen for Sexual Dysfunction in Breastfeeding Patients
Trial Summary
What is the purpose of this trial?
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.
Research Team
Rachel Pope, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Eligibility Criteria
This trial is for postpartum individuals who are at least 18 years old, sexually active, have had a term birth, and plan to breastfeed or pump. They should be between 6 weeks and 6 months postpartum and able to consent in English. Those with preterm delivery, breastfeeding difficulties, estrogen contraindications like cancer or clotting disorders, severe perineal tears, or liver disease cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Baseline Assessment
Participants are randomized into two groups and complete a baseline questionnaire
Treatment
Participants use either vaginal estrogen or moisturizer for 12 weeks
Follow-up
Participants complete follow-up questionnaires at 6 and 12 weeks
Long-term Follow-up
Additional questionnaires administered at 6 months and 1 year to assess long-term benefits
Treatment Details
Interventions
- Estradiol
- Vaginal Moisturizer
Estradiol is already approved in European Union, United States, Canada for the following indications:
- Menopausal symptoms
- Hypoestrogenism
- Osteoporosis prevention
- Breast cancer palliation
- Prostate cancer palliation
- Moderate to severe vasomotor symptoms due to menopause
- Vulvar and vaginal atrophy due to menopause
- Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure
- Prevention of postmenopausal osteoporosis
- Palliative treatment of breast cancer
- Palliative treatment of prostate cancer
- Menopausal symptoms
- Hypoestrogenism
- Osteoporosis prevention
- Breast cancer palliation
- Prostate cancer palliation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor