A Phase 2/3 interventional study of Oxytocin and Placebo in Vaginal Atrophy, Oxytocin Gel and Postmenopausal Women, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Terminated at 1 site in Thailand. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Phase 2/3, Interventional, and Treatment
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.
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.
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's enrollment of 6 is below the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →Department of Medical Services Ministry of Public Health of Thailand is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks
Drug: Placebo
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
Also known as: Oxytocin vaginal gel
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
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
Time frame: Change from baseline VMI at 8 weeks
Comparison of vaginal health index; scoring from vaginal examination
Score 5-25, below 15 mean significant vulvovaginal atrophy from physical examination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline subjective symptom score at 8 weeks
Comparison of vaginal pH between two group
pH from Nitrazine paper test
Time frame: Vaginal pH at 8 weeks
Comparison of adverse events between two group
present of adverse events
Time frame: adverse events within 8 weeks
Plan to share: No
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Department of Medical Services Ministry of Public Health of Thailand