Clinical Trial: Management of Genitourinary Syndrome of Menopause: Safety and Efficacy of a Novel Hormone-Free Vulvovaginal Gel and PROMs. A Pivotal Phase 2 Interventional Clinical Trial.

U.S., May 9 -- ClinicalTrials.gov registry received information related to the study (NCT06962345) titled 'Management of Genitourinary Syndrome of Menopause: Safety and Efficacy of a Novel Hormone-Free Vulvovaginal Gel and PROMs. A Pivotal Phase 2 Interventional Clinical Trial.' on April 29.

Brief Summary: The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) and assess safety and efficacy of a novel hormone-free mucosa composition (XCM(R) INTIM) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess efficacy and safety.

Stud...