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New treatment option for Breastfeeding
Official title Postpartum Vaginal Estrogen for Breastfeeding Patients
ClinicalTrials.gov ID: NCT05457972
What this study is testing
What is Estradiol?
Estradiol is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for breastfeeding.
Also referred to as Imvexxy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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:
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.