Role of Topical Oxytocin Gel in Post-Menopausal Women

Study Overview
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Brief Summary
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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

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

Conditions
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Menopause Related Conditions

Intervention / Treatment
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* Other: oxytocin gel
* Other: placebo gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>patients were treated with an active gel containing oxytocin | Other: oxytocin gel<br>* 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<br>|
| Placebo Comparator: Group B<br>patients were treated with placebo gel without oxytocin | Other: placebo gel<br>* The placebo gel (B) consisted of the gel alone<br>|

What is the study measuring?
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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 |