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

Rajavithi Hospital

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Postmenopausal Women; Oxytocin Gel; Vaginal Maturation Index; Vaginal Atrophy

Treatments: Drug: Placebo; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT05627791

65065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

Oxytocin gel

Experimental group

Description:

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

Treatment:

Drug: Oxytocin

Placebo gel

Placebo Comparator group

Description:

Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks

Treatment:

Drug: Placebo