Role of Topical Oxytocin Gel in Post-Menopausal Women

Menopause Related Conditions Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275270
• Other study ID #: Topical Oxytocin Gel
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: March 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 47 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause Related Conditions

Intervention

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 gel
The placebo gel (B) consisted of the gel alone

Locations

Country	Name	City	State
Egypt	Al-Galaa Teaching Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Al-Azhar University	National research centre

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaginal pallor	A vaginal inspection was performed to establish the presence of vaginal pallor	by the end of 14 successive days of regular use
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cholesterol	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	Triglyceride	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	HDL-C	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	LDL-C	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	C-Reactive Protein (CRP)	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	Random blood sugar (RBS)	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	HBA1C	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	Insulin	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	C-Peptide F	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	Cortisol at morning	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	Interleukin-6 (IL-6)	to assess the serum level in both groups	by the end of 14 successive days of regular use
Primary	Tumor necrosis factor-Alfa (TNF-Alfa)	to assess the serum level in both groups	by the end of 14 successive days of regular use