Hormone cream study aims to unlock pelvic floor secrets
NCT ID NCT01886794
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how hormones influence vaginal tissue in women with pelvic organ prolapse (POP), a condition where pelvic organs slip out of place. Researchers compared postmenopausal women using estrogen cream or placebo to reproductive-age women, examining tissue samples from surgery. The goal was to find tissue differences that could lead to better, noninvasive treatments. However, the study was terminated early with only 7 participants, limiting its conclusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- topical vaginal estrogen cream
- What this could lead to
- If successful, this could help develop targeted, noninvasive treatments for pelvic organ prolapse by understanding tissue differences.
- What could go wrong
- This small, terminated Phase 4 trial had only 7 participants, so results may not be reliable or generalizable. It was exploratory, not designed to prove a treatment works.
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
-
7 people
The number who actually took part.
- Started
-
Jun 2013
- Finished
-
Dec 2023
- 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
-
21 to 70 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 Hide 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: * 21 to 70 years of age * Stage II or greater pelvic organ prolapse (POP) * Individuals electing surgery to treat their POP * Willing and able to comply with study procedures * Willing and able to provide written informed consent Exclusion Criteria: * Contraindication for estrogen cream * Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation * History of connective tissue disease * Previous hysterectomy or pelvic organ prolapse surgery * Known allergic reaction to any agent required by the protocol * Use of hormone therapy in postmenopausal women in the last 90 days * Pregnant or lactating females * History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UTMB Galveston
Galveston, Texas, 77550, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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