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Estrogen cream studied for Post-Birth injury recovery

NCT ID NCT05317364

Symptom relief Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a topical estrogen cream could improve sexual function and reduce incontinence in women who had a severe tear during childbirth. Thirty-eight women used either the cream or a placebo for six months. The trial was terminated early, so the findings are limited.

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 cream
What this could lead to
If effective, this could offer a simple treatment to improve sexual function and reduce incontinence after childbirth injuries.
What could go wrong
The trial was terminated early with only 38 participants, so results are limited. Estrogen cream may not help and carries risks like blood clots or cancer in some women.

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

38 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2026

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 years and older

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: * women who sustained 3rd or 4th degree lacerations * aged 18 years or older * must be able to self apply vaginal cream Exclusion Criteria: * Contraindications to intra-vaginal estrogen therapy (spontaneous DVT, stroke, hormone responsive breast cancer) * tobacco use * allergy to estradiol vaginal cream 0.01% or its constitutions * perineal wound breakdown or infection at 2-week Postpartum visit.

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Conditions

The condition(s) this trial relates to.

Encopresis physiological sexual disorder Urinary Incontinence

As listed by the trial registrant

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

Anal incontinence Obstetric; injury pelvic floor Sexual dysfunction Urinary incontinence

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.