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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
244
Oxytocin gel 600 IU . 1mg/g
Placebo
Oxagon
Cairo, Egypt
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.
Time frame: 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.
Time frame: 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).
Time frame: 60 days
The mean changes in MBS severity, pH, and VMI from the baseline to Days 30 and 75
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Days 30, 60, and 75
The mean changes from the baseline to Days 30, 60, and 75 in Doppler indices measured by transvaginal ultrasound.
Time frame: 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).
Time frame: Days 60, and 75
The mean change from the baseline to Days 60 and 75 in patient-reported psychometric outcomes.
Time frame: 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.
Time frame: Days 30, 60 and 75
The rate of abnormal findings on Days 30, 60, and 75 during the physical, gynecological, and breast examinations.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: Days 30, 60 and 75