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

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rajavithi Hospital
• Treatments: Oxytocin

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