Role of Topical Oxytocin Gel in Post-Menopausal Women

N/ACompletedNCT05275270

Al-Azhar University50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

50

Conditions

Menopause Related Conditions

Interventions

oxytocin gelOTHER

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 gelOTHER

The placebo gel (B) consisted of the gel alone

Eligibility

Sex: FEMALEMin age: 47 YearsMax age: 66 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Al-Galaa Teaching Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

vaginal pallor

A vaginal inspection was performed to establish the presence of vaginal pallor

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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NCT05275270 - Role of Topical Oxytocin Gel in Post-Menopausal Women | Crick | Crick