Clinical trial NCT05275270: Role of Topical Oxytocin Gel in Post-Menopausal Women
Official title: Role of Topical Oxytocin Gel On Vaginal Atrophy, Psycho-sexual and Psychological Function and Metabolic and Inflammatory Parameters in Post-Menopausal Egyptian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause Related Conditions
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2022-03-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: vaginal pallor
timeFrame: by the end of 14 successive days of regular use
measure: intravaginal potential of hydrogen (pH)
timeFrame: by the end of 14 successive days of regular use
measure: Cytological examination of vaginal smear
timeFrame: by the end of 14 successive days of regular use
measure: The Female Sexual Function Index (FSFI) questionnaire
timeFrame: by the end of 14 successive days of regular use
measure: questionnaire to assess the psychological function
timeFrame: by the end of 14 successive days of regular use
measure: Visual Analogue Scale (VAS)
timeFrame: by the end of 14 successive days of regular use
measure: Cholesterol
timeFrame: by the end of 14 successive days of regular use
measure: Triglyceride
timeFrame: by the end of 14 successive days of regular use
measure: HDL-C
timeFrame: by the end of 14 successive days of regular use
measure: LDL-C
timeFrame: by the end of 14 successive days of regular use
measure: C-Reactive Protein (CRP)
timeFrame: by the end of 14 successive days of regular use
measure: Random blood sugar (RBS)
timeFrame: by the end of 14 successive days of regular use
measure: HBA1C
timeFrame: by the end of 14 successive days of regular use
measure: Insulin
timeFrame: by the end of 14 successive days of regular use
measure: C-Peptide F
timeFrame: by the end of 14 successive days of regular use
measure: Cortisol at morning
timeFrame: by the end of 14 successive days of regular use
measure: Interleukin-6 (IL-6)
timeFrame: by the end of 14 successive days of regular use
measure: Tumor necrosis factor-Alfa (TNF-Alfa)
timeFrame: by the end of 14 successive days of regular use
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Galaa Teaching Hospital
Study officials:
References: