A Phase 3 trial investigating a vaginal moisturizer for Menopause is scheduled to complete primary data collection on 2025-09-30, with an anticipated enrollment of 45 participants.
Background
Menopause is a natural biological process marking the end of a woman's reproductive years, typically occurring around age 51. It is characterized by a decline in estrogen production, leading to a range of symptoms including hot flashes, sleep disturbances, and genitourinary syndrome of menopause (GSM), which encompasses vaginal dryness, itching, irritation, and painful intercourse (dyspareunia). Vaginal atrophy, a component of GSM, affects a significant number of postmenopausal women, impacting their quality of life. Current treatments include hormonal therapies, which may not be suitable for all women, and non-hormonal options like lubricants and moisturizers. Hyaluronic acid, known for its hydrating properties, is being explored as a non-hormonal option to alleviate these symptoms.
Trial design
This study, identified as Phase 3, is designed to assess the hydration and acceptability of a vaginal moisturizer containing hyaluronic acid. The trial has an anticipated enrollment of 45 participants and is currently listed with an overall status of NOT_YET_RECRUITING. The conditions being addressed include Vaginismus, Vaginal Atrophy, and Menopause. The intervention involves a hyaluronic acid formulation intended to relieve vaginal dryness, itching, and irritation, with prolonged hydration effects for up to 72 hours.
What this means
The scheduled primary completion of this Phase 3 trial in late 2025 signifies an important step in the development of non-hormonal options for managing menopausal symptoms, particularly vaginal discomfort. While the trial is currently not yet recruiting, its planned completion indicates future progress toward potentially offering a new treatment choice for women experiencing vaginal dryness, irritation, and related conditions during menopause. The focus on hyaluronic acid suggests an emphasis on hydration and local symptom relief, which could benefit individuals who cannot or prefer not to use hormonal therapies.
Source
The information regarding the scheduled primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The details for the study NCT06564883, titled "Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women", were noted with a primary completion date of 2025-09-30 on clinicaltrials.gov.