Postpartum Vaginal Estrogen for Breastfeeding Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity Hospitals Cleveland Medical Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Sexually active
Singleton, term (37 weeks 0 days) birth
Planning to breastfeed or pump during the study period
Disqualifiers
Preterm delivery
Perinatal mortality
History of difficulty breastfeeding
3rd or 4th degree perineal laceration
Trial design
Design model
Parallel
Treatments tested in this trial
Estradiol
DrugImvexxy is an FDA-approved drug produced by TherapeuticsMD.
Vaginal Moisturizer
DeviceIngredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Vaginal EstrogenExperimental treatment 1 intervention
Group B: Vaginal MoisturizerActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 periodSecondary outcomes
1
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 period2
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 period3
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 period4
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 periodSponsors and contacts
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Source ClinicalTrials.gov