Role of Topical Oxytocin Gel in Post-Menopausal Women

NCT05275270 | Completed

• 1 other identifier: Topical Oxytocin Gel
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Menopause Related Conditions

Outcome Measures

Primary Outcomes (18)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

patients were treated with an active gel containing oxytocin

Other: oxytocin gel

Group B

PLACEBO COMPARATOR

patients were treated with placebo gel without oxytocin

Other: placebo gel

Interventions

oxytocin gel OTHER

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

Group A

placebo gel OTHER

The placebo gel (B) consisted of the gel alone

Group B

Eligibility Criteria

• Age: 47 Years - 66 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

Al-Galaa Teaching Hospital

Cairo, Egypt

Location

Related Publications (1)

• Moussa A, Moberg KU, Elgrahy I, Elsayied M, Abdel-Rasheed M, Farouk M, Saad H, Meshaal H. Effect of topical oxytocin gel on vaginal mucosa in postmenopausal Egyptian women: a clinical randomized trial. J Sex Med. 2023 Feb 14;20(2):177-183. doi: 10.1093/jsxmed/qdac021.

  PMID: 36763919 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 11, 2022
• Study Start: December 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)