Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman

Phase 2

Terminated

• Conditions: Vaginal Atrophy; Oxytocin Gel; Postmenopausal Women; Vaginal Maturation Index
• Interventions: Drug: Placebo; Drug: Oxytocin

• Registration Number: NCT05627791
• Lead Sponsor: Rajavithi Hospital

Brief Summary

Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it. But it may increase the risk of breast and endometrial cancer. The oxytocin hormone also promotes positive social behavior, stress regulation, and female sexual arousal. Many previous studies show that topical oxytocin is useful for reducing vaginal atrophy in postmenopausal women.

Detailed Description

Random and conducted on 56 postmenopausal women who meet the inclusion criteria and excluded participants that have exclusion criteria. All women provided written informed consent before data collection.

1. st Visit: The vagina was assessed regarding infection and any abnormal discharge. The participants were evaluated vaginal signs of vaginal atrophy by per vaginal examination and assessed vaginal health index score. The subjective symptoms were assessed by The most bothersome score. The vaginal pH was tested with a Nitrazine paper. The vaginal swab was done and the specimen was sent for a cytological test - vaginal maturation index evaluation (VMI). The participants were separated into two groups 1. Oxytocin gel group and 2. Placebo gel group then applied gel 1 ml. (400IU of oxytocin in oxytocin gel) per day for 8 weeks consecutively. The subjective symptoms were assessed at 2 and 4 weeks by phone.

2. nd Visit: The participants were assessed the same as 1st visit that recorded vaginal health index score, subjective symptoms, vaginal pH, and vaginal maturation index evaluation.

Study Timeline

• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-25
• Study First Posted: 2022-11-28
• Study Start: 2022-11-30
• Primary Completion: 2023-07-31
• Status Verified: 2023-08
• Study Completion: 2023-08-28
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

• Thai menopausal women aged between 50-70 years who visit Rajavithi gynecology OPD with informed consent with good communication in the Thai language.

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Exclusion Criteria

• Have acute vulvovaginitis (vaginal swab for wet smear and KOH)
• Patients who have used hormonal replacement therapy within 12 months
• Patients with a history of smoking
• Patients who have used vaginal lubricant or moisturizer
• Patients with an allergic history of oxytocin or gel components
• Morbid obesity BMI > 30 kg/m2
• Patients who have used vitamin E supplement
• Patients who unable to perform per vaginal examination

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo gel	Placebo	Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks
Oxytocin gel	Oxytocin	Oxytocin gel 400IU per 1 ml (on HPMC 4,000 cps base gel), applied at vaginal canal 1 ml per day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Comparison of vaginal cytology test for vaginal maturation index measurement	Change from baseline VMI at 8 weeks	VMI = 0.2 × % parabasal cells+0.6 × % intermediate cells+1.0 × % superficial cells score below 52 mean significant vulvovaginal atrophy

Secondary Outcome Measures

Name	Time	Method
Comparison of vaginal pH between two group	Vaginal pH at 8 weeks	pH from Nitrazine paper test
Comparison of adverse events between two group	adverse events within 8 weeks	present of adverse events
Comparison of subjective symptoms by The most bothersome symptoms score	Change from baseline subjective symptom score at 8 weeks	score from 0-4, 0 = absent, 4 = severe symptom
Comparison of vaginal health index; scoring from vaginal examination	Change from baseline vaginal health index score at 8 weeks	Score 5-25, below 15 mean significant vulvovaginal atrophy from physical examination

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand