Clinical trial NCT06514586: The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy
Official title: The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Vaginal Atrophy
Genitourinary Syndrome of Menopause
Vulvar Atrophy
Keywords: vulvovaginal atrophy
postmenopause
vulvovaginal
atrophy
Lead sponsor: Oxagon
Sponsor class: NETWORK
First posted: 2024-07-23
Enrollment: 244
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Double-Blinded Randomized Controlled Trial The study includes 2 arms. The subjects will be randomized to receive (apply) either oxytocin topical gel (intervention arm) or placebo gel (control arm).
Primary purpose: TREATMENT

Brief 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.

Detailed description: A Phase three randomized, double-blinded, placebo- controlled study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM. This study shall include 242 subjects. After screening , subject who meet eligibility criterial will be randomized in a 1:1 ratio to receive wither study intervention or placebo to be applied once daily for sixty days and followed up extra fifteen days. objectives is to evaluate the efficacy and effectiveness of topical oxytocin gel compared with placebo in improving postmenopausal vaginal atrophy symptoms in women with GSM , also assessing the safety and tolerability of topical oxytocin gel.

Eligibility criteria: Inclusion Criteria:

1. Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.
2. Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and/or dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.

4. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH \> 5.0 at screening 6. A level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) \> 40 milli International Units (mIU)/ml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits

Exclusion Criteria:

1. Previous treatment with other local non-hormonal moisturizers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion.
2. Women taking systemic hormone replacement or pills within the last 6 months.
3. Current or history of endometrial hyperplasia or uterine/endometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding
4. Any untreated urogenital infection within 14 days prior to randomization.
5. Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.
6. Critically ill patients.
7. Patients with severe renal impairment (GFR \< 30 ml/min/1.73 m2 as measured by the Cockcroft-Gault formula).
8. Patients with known severe hepatic impairment (Child-Pugh C; 10 - 15 points), biliary cirrhosis, or cholestasis.
9. Patients with known or suspected allergy or any contraindications to oxytocin.

Primary outcomes:
measure: The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment.
timeFrame: 60 days
measure: The mean change from the baseline to Day 60 of the vaginal pH
timeFrame: 60 days
measure: The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI)
timeFrame: 60 days
Secondary outcomes:
measure: The mean changes in MBS severity, pH, and VMI from the baseline to Days 30 and 75
timeFrame: Days 30 and 75
measure: The percentage of subjects identified as Responders on days 60 and 75.
timeFrame: Days 60 and 75
measure: The mean change from the baseline to Days 30, 60, and 75 of the physical examination of the vulva and vagina
timeFrame: Days 30, 60, and 75
measure: The mean changes from the baseline to Days 30, 60, and 75 in Vaginal Wall Thickness as measured by transvaginal ultrasound.
timeFrame: Days 30, 60, and 75
measure: The mean changes from the baseline to Days 30, 60, and 75 in Doppler indices measured by transvaginal ultrasound.
timeFrame: Days 30, 60, and 75
measure: The mean change from the baseline to Days 60 and 75 in selected items from the Female Sexual Function Index (FSFI).
timeFrame: Days 60, and 75
measure: The mean change from the baseline to Days 60 and 75 in patient-reported psychometric outcomes.
timeFrame: Days 60 and 75
measure: 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.
timeFrame: Days 30, 60 and 75
measure: The rate of abnormal findings on Days 30, 60, and 75 during the physical, gynecological, and breast examinations.
timeFrame: Days 30, 60 and 75
measure: The rate of abnormal findings on Days 30, 60, and 75 of the transvaginal ultrasound for women with an intact uterus only.
timeFrame: Days 30, 60 and 75
measure: 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%.
timeFrame: Days 30,and 60
measure: The incidence of AEs reported by the subjects, summarized by system organ class, severity, and relationship to study intervention, over the course of treatment.
timeFrame: Days 30, 60 and 75
Other outcomes:
measure: The mean change in weight from baseline to days 60 and 75, and BMI from baseline to day 75.
timeFrame: Days 60 and 75
measure: The number of subjects reporting changes in appetite (satiety/hunger) on days 30, 60, and 75.
timeFrame: Days 30, 60 and 75
measure: The mean change in fasting blood glucose, HbA1C, and insulin levels from baseline to days 60.
timeFrame: Day 60
measure: The mean change in blood pressure from baseline to days 30, 60, and 75.
timeFrame: Days 30, 60 and 75
measure: The mean change in IL-6 from baseline to days 60.
timeFrame: Day 60
measure: The mean changes in metabolic bone marker (Alkaline phosphatase (ALP)) from baseline to day 60
timeFrame: Day 60
Locations:
city: Cairo
country: Egypt
facility: Oxagon
Study officials:
affiliation: Azhar Univeristy
name: Assem Anwar
role: PRINCIPAL_INVESTIGATOR
References: