The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy
NCT Number: NCT06514586
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Vaginal Atrophy|Genitourinary Syndrome of Menopause|Vulvar Atrophy
Interventions: DRUG: Oxytocin|OTHER: Hydroxypropyl methylcellulose
Sponsor: Oxagon
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 244
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-08
Locations: Oxagon, Cairo, Egypt

Summary:
A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.

Primary Outcome Measures: The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment., MBS is a moderate to severe symptom identified as the most bothersome by the subject at baseline, recorded as none, mild, moderate, or severe was analyzed using the score values of 0, 1, 2, or 3, respectively. Symptoms include vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain (dyspareunia), or bleeding associated with sexual activity., 60 days|The mean change from the baseline to Day 60 of the vaginal pH, Vaginal pH as measured by a pH strip applied directly to the lateral wall of the vagina, recording the pH value (to one decimal) according to the comparison to the color chart., 60 days|The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI), VMI is calculated using the Meisels'(Meisels, 1967) formula: (0 \* Parabasal Cells) + (0.5 \* Intermediate Cells) + (1 \* Superficial Cells)., 60 days
Secondary Outcome Measures: The mean changes in MBS severity, pH, and VMI from the baseline to Days 30 and 75, Days 30 and 75|The percentage of subjects identified as Responders on days 60 and 75., A responder is a subject meeting all the following criteria: at least 1 point improvement (decrease) in the severity of the MBS, at least a 0.5-point decrease in the vaginal pH, and at least 20% improvement in the VMI., Days 60 and 75|The mean change from the baseline to Days 30, 60, and 75 of the physical examination of the vulva and vagina, Assessment of the physical signs of VA (Vaginal secretions, Vaginal Epithelial Integrity, Vaginal Epithelial Surface Thickness, and Vaginal Color) as evaluated by the physician/gynecologist and corresponding to none, mild, moderate, or severe atrophy and analyzed using the score values of 0, 1, 2, and 3, respectively., Days 30, 60, and 75|The mean changes from the baseline to Days 30, 60, and 75 in Vaginal Wall Thickness as measured by transvaginal ultrasound., Days 30, 60, and 75|The mean changes from the baseline to Days 30, 60, and 75 in Doppler indices measured by transvaginal ultrasound., Days 30, 60, and 75|The mean change from the baseline to Days 60 and 75 in selected items from the Female Sexual Function Index (FSFI)., Days 60, and 75|The mean change from the baseline to Days 60 and 75 in patient-reported psychometric outcomes., Days 60 and 75|The number and percentage of subjects on Days 30, 60, and 75 reporting Treatment-Emergent Adverse Event (TEAE), defined as any AE that occurs on or after the application of the first dose of the study intervention., Days 30, 60 and 75|The rate of abnormal findings on Days 30, 60, and 75 during the physical, gynecological, and breast examinations., Days 30, 60 and 75|The rate of abnormal findings on Days 30, 60, and 75 of the transvaginal ultrasound for women with an intact uterus only., Days 30, 60 and 75|The mean medication incompliance rate (%) will be calculated in Days 30, and 60 for each subject as [(Total number of missed doses) / (Expected number of applications)] *100%., Days 30,and 60|The incidence of AEs reported by the subjects, summarized by system organ class, severity, and relationship to study intervention, over the course of treatment., Days 30, 60 and 75
Other Outcome Measures: The mean change in weight from baseline to days 60 and 75, and BMI from baseline to day 75., Days 60 and 75|The number of subjects reporting changes in appetite (satiety/hunger) on days 30, 60, and 75., Days 30, 60 and 75|The mean change in fasting blood glucose, HbA1C, and insulin levels from baseline to days 60., Day 60|The mean change in blood pressure from baseline to days 30, 60, and 75., Days 30, 60 and 75|The mean change in IL-6 from baseline to days 60., Day 60|The mean changes in metabolic bone marker (Alkaline phosphatase (ALP)) from baseline to day 60, Day 60