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Could a simple estrogen cream restore sexual health for breastfeeding moms?

NCT ID NCT05457972

Symptom relief Sponsor: University Hospitals Cleveland Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests whether a vaginal estrogen cream (Imvexxy) can improve sexual function in breastfeeding women who are 6 weeks to 6 months postpartum. About 100 participants will either use the estrogen cream or a placebo-like vitamin E suppository for 12 weeks. The goal is to see if the cream helps with desire, arousal, and overall sexual satisfaction without interfering with breastfeeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Estradiol (vaginal estrogen cream, brand name Imvexxy)
What this could lead to
If it works, this could offer a safe, effective option to improve sexual function and vaginal health for breastfeeding women without affecting milk supply.
What could go wrong
This is a small Phase 4 trial with only 100 participants, so results may not apply to all women. The estrogen cream may cause local irritation or spotting, and long-term effects during breastfeeding are not fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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 these conditions, active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions, known anaphylactic reaction, angioedema, or hypersensitivity to estrogen, hepatic impairment or disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

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Conditions

The condition(s) this trial relates to.

Breast Feeding physiological sexual disorder postmenopausal atrophic vaginitis psychologic dyspareunia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breastfeeding Postpartum sexual dysfunction Vaginal atrophy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

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