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Could a collagen pill ease menopause discomfort?

NCT ID NCT07151482

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a daily oral supplement containing bioactive collagen peptides can improve quality of life for menopausal women with vaginal dryness, pain, and mild urinary incontinence. 43 women will take the supplement for 16 weeks and report changes in symptoms and sexual function. The goal is to find a non-hormonal option for those who cannot or prefer not to use hormone therapy.

What this could mean

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

Active substance
bioactive collagen peptides (BCP) and other functional ingredients
What this could lead to
If it works, this could offer a non-hormonal option to ease menopause-related vaginal discomfort and urinary leakage, improving quality of life.
What could go wrong
This is a small, early-stage study with only 43 people and no placebo group, so results may not be conclusive or widely applicable. Dietary supplements often show limited effects.

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.

Participants

About 43 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Feb 2028

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.

Who is studied

Menopausal women (at least 12 months since last menstrual period or bilateral oophorectomy). Patients with Genitourinary Syndrome in particular suffering of vaginal dryness and/or urinary incontinence.

Ages

45 to 65 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: * Menopausal women (at least 12 months since last menstrual period or bilateral oophorectomy) * Patients with Genitourinary Syndrome and the presence of vulvovaginal atrophy/vestibular trophism alteration (defined as Vaginal Health Index - VHI - less than 15; and Vestibular Trophic Health Score - VeTH - more than 5) and/or initial urinary incontinence based on patient history (stress incontinence , urge incontinence, nicturia reported by patients,) positive IU tests (Stamey score 1: loss of urine with sudden increase in abdominal pressure such as from coughing, sneezing, or laughing) and on a standardized stress test provocation \[(cough test supine and in a standing position with a full bladder (300 ml)\] in healthy post-menopausal women and/or positive OABSS score for overactive bladder. * Patients willing to provide Informed consent to participate in the study. * Women aged between 45 and 65 years. Exclusion Criteria: * Renal insufficiency or sever nephropathy. * In case of known hypersensitivity to one or more of the components contained in the food supplement. * Active or recent (30 days) genitourinary tract infection. * Abnormal uterine bleeding. * Use of lubricants or any other local or systemic preparations, within the 30 days prior to the study. * Genital prolapse (grade II - III according to the Pelvic Organ Prolapse-Quantification, POP-Q, system classification). * Serious or chronic condition that could interfere with study compliance. * Treatment with hormones or other medicines to relieve menopausal symptoms within the 3 months prior the study.

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Conditions

The condition(s) this trial relates to.

postmenopausal atrophic vaginitis

As listed by the trial registrant

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

Genitourinary syndrome of menopause

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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