Role of Topical Oxytocin Gel in Post-Menopausal Women

Al-Azhar University

Status: Completed

Conditions: Menopause Related Conditions

Treatments: Other: placebo gel; Other: oxytocin gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05275270

Topical Oxytocin Gel

Details and patient eligibility

About

Aim of the current study:

To evaluate the effect of a14 day treatment period with local intravaginal application of an oxytocin-containing gel on vaginal atrophy, psychosexual and psychological/cognitive function, and metabolic, stress, and inflammatory parameters in Egyptian post-menopausal women

Enrollment: 50 patients

Sex: Female

Ages: 47 to 66 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The women were post-menopausal and were between 47 and 67 years old
• The women's last menstruation had occurred more than one year prior to the study
• The women had an established vaginal atrophy
• The women scored < 26 in the Female Sexual Function Index (FSFI)
• The women had an active sexual relationship

Exclusion criteria

• Women who smoked
• Women who used hormone replacement therapy
• Women using a vaginal lubricant
• Women having any vaginal bleeding or any breast diseases
• Women having any undiagnosed genitalia disorder
• Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular disease, or psychiatric disease

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

patients were treated with an active gel containing oxytocin

Treatment:

Other: oxytocin gel

Group B

Placebo Comparator group

Description:

patients were treated with placebo gel without oxytocin

Treatment:

Other: placebo gel