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

Study Overview
=================
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. 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. 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.

Official Title
-----------------
Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman: A Randomized Placebo-controlled Trial

Conditions
-----------------
Vaginal Atrophy, Oxytocin Gel, Postmenopausal Women, Vaginal Maturation Index

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin gel<br>Oxytocin gel 400IU per 1 ml (on HPMC 4,000 cps base gel), applied at vaginal canal 1 ml per day for 8 weeks | Drug: Oxytocin<br>* Oxytocin vaginal gel that have oxytocin 400IU/1ml of gel, base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0<br>* Other names: Oxytocin vaginal gel;|
| Placebo Comparator: Placebo gel<br>Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks | Drug: Placebo<br>* Placebo gel that have base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0 without oxytocin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of vaginal health index; scoring from vaginal examination | Score 5-25, below 15 mean significant vulvovaginal atrophy from physical examination | Change from baseline vaginal health index score at 8 weeks | 
| Comparison of subjective symptoms by The most bothersome symptoms score | score from 0-4, 0 = absent, 4 = severe symptom | Change from baseline subjective symptom score at 2 weeks | 
| Comparison of subjective symptoms by The most bothersome symptoms score | score from 0-4, 0 = absent, 4 = severe symptom | Change from baseline subjective symptom score at 4 weeks | 
| Comparison of subjective symptoms by The most bothersome symptoms score | score from 0-4, 0 = absent, 4 = severe symptom | Change from baseline subjective symptom score at 8 weeks | 
| Comparison of vaginal pH between two group | pH from Nitrazine paper test | Vaginal pH at 8 weeks | 
| Comparison of adverse events between two group | present of adverse events | adverse events within 8 weeks |