Role of Topical Oxytocin Gel in Post-Menopausal Women

Role of Topical Oxytocin Gel On Vaginal Atrophy, Psycho-sexual and Psychological Function and Metabolic and Inflammatory Parameters in Post-Menopausal Egyptian Women

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

Study Overview

• Status: Completed
• Conditions: Menopause Related Conditions
• Intervention / Treatment: Other: oxytocin gel; Other: placebo gel

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al-Galaa Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 62 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; patients were treated with an active gel containing oxytocin	Other: oxytocin gel; The active oxytocin gel (A) consisted of oxytocin dissolved in a gel-based on hypromellose with a pH of 3.8. 1 ml of gel contained 600 IU of oxytocin
Placebo Comparator: Group B; patients were treated with placebo gel without oxytocin	Other: placebo gel; The placebo gel (B) consisted of the gel alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vaginal pallor	A vaginal inspection was performed to establish the presence of vaginal pallor	by the end of 14 successive days of regular use
intravaginal potential of hydrogen (pH)	Intravaginal pH was measured by a litmus paper applied intravaginally	by the end of 14 successive days of regular use
Cytological examination of vaginal smear	A piece of cotton was applied on a stick ( a vaginal swab) to the posterior vaginal wall to collect material from the epithelium	by the end of 14 successive days of regular use
The Female Sexual Function Index (FSFI) questionnaire	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.	by the end of 14 successive days of regular use
questionnaire to assess the psychological function	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.	by the end of 14 successive days of regular use
Visual Analogue Scale (VAS)	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.	by the end of 14 successive days of regular use
Cholesterol	to assess the serum level in both groups	by the end of 14 successive days of regular use
Triglyceride	to assess the serum level in both groups	by the end of 14 successive days of regular use
HDL-C	to assess the serum level in both groups	by the end of 14 successive days of regular use
LDL-C	to assess the serum level in both groups	by the end of 14 successive days of regular use
C-Reactive Protein (CRP)	to assess the serum level in both groups	by the end of 14 successive days of regular use
Random blood sugar (RBS)	to assess the serum level in both groups	by the end of 14 successive days of regular use
HBA1C	to assess the serum level in both groups	by the end of 14 successive days of regular use
Insulin	to assess the serum level in both groups	by the end of 14 successive days of regular use
C-Peptide F	to assess the serum level in both groups	by the end of 14 successive days of regular use
Cortisol at morning	to assess the serum level in both groups	by the end of 14 successive days of regular use
Interleukin-6 (IL-6)	to assess the serum level in both groups	by the end of 14 successive days of regular use
Tumor necrosis factor-Alfa (TNF-Alfa)	to assess the serum level in both groups	by the end of 14 successive days of regular use

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: Topical Oxytocin Gel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No