Menopause Related Conditions
Conditions
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
Interventions
OTHERoxytocin 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
OTHERplacebo gel
The placebo gel (B) consisted of the gel alone
Sponsors
National Research Centre, Egypt
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
47 Years to 66 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBA1C | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| Insulin | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| vaginal pallor | by the end of 14 successive days of regular use | A vaginal inspection was performed to establish the presence of vaginal pallor |
| intravaginal potential of hydrogen (pH) | by the end of 14 successive days of regular use | Intravaginal pH was measured by a litmus paper applied intravaginally |
| Cytological examination of vaginal smear | by the end of 14 successive days of regular use | A piece of cotton was applied on a stick ( a vaginal swab) to the posterior vaginal wall to collect material from the epithelium |
| The Female Sexual Function Index (FSFI) questionnaire | by the end of 14 successive days of regular use | 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. |
| questionnaire to assess the psychological function | by the end of 14 successive days of regular use | 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. |
| Visual Analogue Scale (VAS) | by the end of 14 successive days of regular use | 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. |
| Cholesterol | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| Triglyceride | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| HDL-C | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| LDL-C | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| C-Reactive Protein (CRP) | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| Random blood sugar (RBS) | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| C-Peptide F | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| Cortisol at morning | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| Interleukin-6 (IL-6) | by the end of 14 successive days of regular use | to assess the serum level in both groups |
| Tumor necrosis factor-Alfa (TNF-Alfa) | by the end of 14 successive days of regular use | to assess the serum level in both groups |
Countries
Egypt
Outcome results
None listed