Nonhormonal vulvovaginal gel to relieve menopausal vulvovaginal symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Postmenopausal women with symptoms of GSM and a Vaginal Health Index ≤15 will apply a novel hormone-free gel (XCMIM20m) topically to the vulvar area, 1 mL twice daily, for 8 weeks. Participants will complete the Day-to-Day Impact of Vaginal Aging (DIVA) patient-reported outcome measure at baseline and after 8 weeks to capture symptom and quality-of-life changes. The trial excludes recent users of systemic or vaginal hormone therapies and topical vulvovaginal products to limit confounding. Safety, acceptability, and symptom change will be recorded to provide preliminary data on tolerability and potential effectiveness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mucosa Innovations S.L.
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Manuel Albi, MD, PhD — Hospital La Luz
• Study coordinator: Jorge Rodríguez-Vilaboa
• Email: jorge.vilaboa@mucosainnovations.com
• Phone: +34 629 288 597

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.