A Phase 4 interventional study of Estradiol and Vaginal Moisturizer in Breastfeeding, Postpartum Sexual Dysfunction and Vaginal Atrophy, sponsored by University Hospitals Cleveland Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University Hospitals Cleveland Medical Center · Phase 4, Interventional, and Treatment
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.
This will be a prospective, randomized clinical trial of postpartum breastfeeding patients. Postpartum patients at University Hospitals (UH) MacDonald Women's Hospital will be evaluated for inclusion/exclusion by review of their medical record by the study investigators prior to discharge home. The study will then be discussed with the eligible patients privately. If they agree to participate, informed consent will be obtained. At this time, contact information will be obtained for all consenting patients.
Between 5 and 6 weeks postpartum, all consented patients will be contacted via their preferred form of communication. Inclusion criteria and desire for continued study participation will be verified prior to randomization. A baseline REDCap questionnaire will be texted or emailed to confirmed study participants. UH REDCap is a HIPAA-certified, secure, web-based data storage platform for research studies.
The patient will then be randomized in a 1:1 ratio into two study groups: vaginal estrogen or vaginal moisturizer. Randomization will be performed using blocking with a block size of 10 and a 1:1 allocation ratio. The randomization sequence will be generated using a random number table.
After randomization, but not prior to 6 weeks postpartum, the investigational drug service courier service will deliver softgel inserts of vaginal estrogen to the homes of participants randomized to the estrogen arm. Study investigators will deliver vaginal moisturizer to the homes of participants randomized to the placebo arm. Study participants will be provided with an instructional handout including information about how and how often to use the inserts or the moisturizer. Participants will be instructed to start using the inserts or lubricant when they receive the delivery. This will be considered the start of the study period.
During the study period, participants will use either estrogen or vaginal moisturizer nightly for two weeks and then twice weekly for ten weeks. Each week during the study period, participants will receive a message via their preferred communication method with five questions:
Did you experience any change in your health this week?
6 and 12 weeks into the study period, the patient will be contacted by their preferred communication method and requested to complete a questionnaire via UH REDCap.
The initial study questionnaire will include questions about demographics, gravidity and parity, prior deliveries (including mode of delivery, obstetric lacerations, and infant feeding), baseline sexual activity, prior pelvic surgery, chronic pain disorders, and plans for infant feeding. The 6 and 12-week study questionnaires will include the FSFI, the GAD-7 anxiety questionnaire, the Edinburgh Postnatal Depression Scale (EPDS), and the urinary distress inventory (UDI-6), the vaginal assessment scale (VAS), the Sexual Function Questionnaire Medical Impact Scale (SFQ-MIS), and the Female Sexual Distress Scale-Revised (FSDS-R) as well as questions about sexual activity and plans for infant feeding.
Questionnaire responses will be reviewed by a study investigator after completion by the patient. Any patients whose questionnaires indicate possible depression (EPDS score 10+), thoughts of self-harm (any answer other than "never" on EPDS question 10), or moderate to severe anxiety (GAD-7 score 10+) will be evaluated for safety by a physician study investigator and referred to UH Reproductive Behavioral Health.
In order to assess long term benefits of estrogen therapy in the early postpartum period, additional questionnaires will be administered at 6 months and 1 year to patients. The study intervention period will last 12 weeks, after which no additional vaginal estrogen or vaginal moisturizer will be administered to participants. Patients desiring to continue treatment after the 12-week study intervention period will be referred to their postpartum care provider. Patients will be instructed to stop estrogen use after they have completed breastfeeding.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Estradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks.
Drug: Estradiol
Vaginal moisturizer, daily for two weeks then twice weekly for ten weeks.
Device: Vaginal Moisturizer
Imvexxy is an FDA-approved drug produced by TherapeuticsMD.
Also known as: Imvexxy
Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).
Also known as: Carlson Key-E Suppositories
Total Female Sexual Function Index (FSFI) score
Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning. A score of 26 has been validated as a threshold for diagnosing female sexual dysfunction.
Time frame: Up to 12 weeks into study period
Desire as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 1.2-6, with a higher score indicating better functioning.
Time frame: Up to 12 weeks into study period
Arousal as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Time frame: Up to 12 weeks into study period
Lubrication as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Time frame: Up to 12 weeks into study period
Orgasm as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Time frame: Up to 12 weeks into study period
Satisfaction as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0.8-6, with a higher score indicating better functioning.
Time frame: Up to 12 weeks into study period
Pain as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Time frame: Up to 12 weeks into study period
Intercourse resumption
Number of weeks until resumption of intercourse after delivery
Time frame: Up to 12 weeks into study period
Serum estradiol levels
Time frame: Up to 12 weeks after study medication initiation
Breast milk estradiol level
Time frame: Up to 12 weeks after study medication initiation
Plan to share: No
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Studies of the drug tested here: Estradiol
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