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| Name | Class |
|---|---|
| National Research Centre, Egypt | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | patients were treated with an active gel containing oxytocin |
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| Group B | Placebo Comparator | patients were treated with placebo gel without oxytocin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Galaa Teaching Hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36763919 | Derived | 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. |
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| placebo gel | Other | The placebo gel (B) consisted of the gel alone |
|
| 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 |