Application of the estrogen threshold hypothesis to the physiologic hypoestrogenemia of lactation.
Sanjay K Agarwal, Julie Kim, Lisa M Korst...
https://pubmed.ncbi.nlm.nih.gov/25565323Actively Recruiting
Led by University Hospitals Cleveland Medical Center · Updated on 2026-03-10
100
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying sexual dysfunction in breastfeeding postpartum patients to see if using vaginal estrogen cream improves sexual function compared to not using it. This randomized clinical trial focuses on patients who have recently given birth and are breastfeeding or pumping, aiming to better understand treatment options during the postpartum period. Participants will be randomly assigned to one of two groups: one group will use estradiol vaginal inserts, and the other will use a vaginal moisturizer. Both treatments start after 6 weeks postpartum, with daily use for two weeks followed by twice-weekly use for ten weeks. Study supplies will be delivered to participants' homes, and instructions on usage will be provided. The study period lasts 12 weeks, with follow-up questionnaires at 6 weeks, 12 weeks, 6 months, and 1 year to assess long-term effects. Participants will complete questionnaires about sexual function, anxiety, depression, urinary symptoms, and vaginal health using secure online tools. Weekly messages will check breastfeeding status, sexual activity, vaginal pain, treatment use, and health changes. Safety monitoring will be conducted, and those showing signs of depression or anxiety will be referred for further care. The study measures sexual function scores up to 12 weeks and tracks participant wellbeing over one year.
CONDITIONS
Postpartum Vaginal Estrogen for Breastfeeding Patients
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - Up to hospital discharge after delivery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person at hospital before discharge)
Duration - Between 5 and 6 weeks postpartum
Participants provide informed consent and complete a baseline questionnaire about demographics, prior deliveries, and baseline sexual activity.
1 baseline contact (remote via text or email)
Duration - 12 weeks
Participants use either vaginal estrogen inserts or vaginal moisturizer nightly for two weeks, then twice weekly for ten weeks. Weekly messaging collects information on breastfeeding, sexual activity, vaginal pain, product use, and health changes.
Weekly remote contacts with messages and questionnaires; 2 remote questionnaires at Weeks 6 and 12
Duration - Up to 1 year after treatment
Participants complete additional questionnaires at 6 months and 1 year to assess longer-term outcomes after stopping study treatment.
2 remote questionnaire contacts
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
S
Susan D Wherley, MD
R
Rosemary Brewka
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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