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NCT05627791
Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman
Conditions: Vaginal Atrophy, Oxytocin Gel, Postmenopausal Women, Vaginal Maturation Index
Sex: Female
Ages: 50 Years – 70 Years
Healthy volunteers: 1
Phase: PHASE2, PHASE3
Enrollment: 56
Sponsor: Rajavithi Hospital
Location: Thailand
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.
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 monthsPatients with a history of smokingPatients who have used vaginal lubricant or moisturizerPatients with an allergic history of oxytocin or gel componentsMorbid obesity BMI > 30 kg/m2Patients who have used vitamin E supplementPatients who unable to perform per vaginal examination
Source: ClinicalTrials.gov (NCT05627791). StuddyBuddy aggregates publicly available trial information.