New gel may ease menopause symptoms without hormones
NCT ID NCT06962345
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new hormone-free gel for women with genitourinary syndrome of menopause (GSM), which causes vaginal dryness, pain, and other symptoms. About 80 postmenopausal women will use the gel for 8 weeks. Researchers will measure changes in quality of life using a questionnaire.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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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: * Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15). * Patient must be postmenopausal with at least 1 year without a menstrual period. * Patient must consider that her quality of life is affected by GSM symptoms * Patient not followed due to any gynecological disease. * All participants must be able to understand and to fill in the self-reported questionnaires. Exclusion Criteria: * Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning. * Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week. * Patients with history of vulvar, vaginal and/or cervical malignancy. * Patients having received radiotherapy treatment in the pelvic and/or genital region. * Patients with any type of disease that causes alteration of collagenogenesis. * Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months. * Patients having received laser and/or radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions. * Patients with active urinary and/or genital tract infection. * Patients with history of malignant neoplasm of the urinary system. * Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8). * Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification. * Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study. * Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and/or following the established procedures.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Mucosa Innovations S.L.
RECRUITINGMadrid, Madrid, 28023, Spain
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