Role of Topical Oxytocin Gel in Post-Menopausal Women

Not Applicable

Completed

• Conditions: Menopause Related Conditions
• Interventions: Other: placebo gel; Other: oxytocin gel

• Registration Number: NCT05275270
• Lead Sponsor: Al-Azhar University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Study First Submitted: 2022-02-22
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	placebo gel	patients were treated with placebo gel without oxytocin
Group A	oxytocin gel	patients were treated with an active gel containing oxytocin

Primary Outcome Measures

Name	Time	Method
intravaginal potential of hydrogen (pH)	by the end of 14 successive days of regular use	Intravaginal pH was measured by a litmus paper applied intravaginally
Cytological examination of vaginal smear	by the end of 14 successive days of regular use	A piece of cotton was applied on a stick ( a vaginal swab) to the posterior vaginal wall to collect material from the epithelium
LDL-C	by the end of 14 successive days of regular use	to assess the serum level in both groups
Cholesterol	by the end of 14 successive days of regular use	to assess the serum level in both groups
HBA1C	by the end of 14 successive days of regular use	to assess the serum level in both groups
C-Peptide F	by the end of 14 successive days of regular use	to assess the serum level in both groups
Cortisol at morning	by the end of 14 successive days of regular use	to assess the serum level in both groups
Triglyceride	by the end of 14 successive days of regular use	to assess the serum level in both groups
HDL-C	by the end of 14 successive days of regular use	to assess the serum level in both groups
C-Reactive Protein (CRP)	by the end of 14 successive days of regular use	to assess the serum level in both groups
Random blood sugar (RBS)	by the end of 14 successive days of regular use	to assess the serum level in both groups
Insulin	by the end of 14 successive days of regular use	to assess the serum level in both groups
The Female Sexual Function Index (FSFI) questionnaire	by the end of 14 successive days of regular use	19 questions to measure sexual function in six domains, including sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. We applied the modified FSFI, which included 6 questions to measure sexual function in the six domains (one question for each). The score for each domain is evaluated by six levels (from 0 to 6); the lowest is 0, and the maximum is 6. The sexual function was assessed by the sum of all 6 domains.
Visual Analogue Scale (VAS)	by the end of 14 successive days of regular use	to assess the severity of the vaginal pain if present. The score ranges from 0 if no pain to 10 for the severest degree of pain.
vaginal pallor	by the end of 14 successive days of regular use	A vaginal inspection was performed to establish the presence of vaginal pallor
questionnaire to assess the psychological function	by the end of 14 successive days of regular use	It consisted of 6 domains, including social cognition, memory, social trust, prosocial behavior, aggressive behavior, and depression, which included 2 questions for memory and depression and one question for social cognition, social trust, prosocial behavior, and aggressive behavior. The score for each domain is evaluated by 4 levels (from 0 to 3), the lowest is 0, and the maximum is 3. The psychological function was assessed by the sum of all domains.
Tumor necrosis factor-Alfa (TNF-Alfa)	by the end of 14 successive days of regular use	to assess the serum level in both groups
Interleukin-6 (IL-6)	by the end of 14 successive days of regular use	to assess the serum level in both groups

Trial Locations

Locations (1)

Al-Galaa Teaching Hospital; 🇪🇬 Cairo, Egypt