Trial · Interventional

CompletedNot applicableRegistry data

Role of Topical Oxytocin Gel in Post-Menopausal Women

NCTNCT05275270Other idTopical Oxytocin Gel

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 50 participants (actual)
Sponsor: Al-Azhar University · Other
Design: Randomized · Double masking
Countries: 1 country
Egypt
Start: 1 Dec 2020
Primary completion: 31 May 2021
Completion: 31 May 2021
First posted: 11 Mar 2022
Last update posted: 11 Mar 2022
Conditions: Menopause Related Conditions

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

N/A
Role of Topical Oxytocin Gel in Post-Menopausal Women
NCT05275270
1 Dec 2020 to 31 May 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

oxytocin gelOther
placebo gelOther

Arms2

Active comparator
Group A
patients were treated with an active gel containing oxytocin
Placebo comparator
Group B
patients were treated with placebo gel without oxytocin

Primary outcomes18

Outcomes the sponsor listed as primary.

vaginal pallor
Time frame · by the end of 14 successive days of regular use
Registry description
A vaginal inspection was performed to establish the presence of vaginal pallor
intravaginal potential of hydrogen (pH)
Time frame · by the end of 14 successive days of regular use
Registry description
Intravaginal pH was measured by a litmus paper applied intravaginally
Cytological examination of vaginal smear
Time frame · by the end of 14 successive days of regular use
Registry description
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
Time frame · by the end of 14 successive days of regular use
Registry description
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
Time frame · by the end of 14 successive days of regular use
Registry description
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)
Time frame · by the end of 14 successive days of regular use
Registry description
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
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
Triglyceride
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
HDL-C
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
LDL-C
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
C-Reactive Protein (CRP)
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
Random blood sugar (RBS)
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
HBA1C
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
Insulin
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
C-Peptide F
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
Cortisol at morning
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
Interleukin-6 (IL-6)
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups
Tumor necrosis factor-Alfa (TNF-Alfa)
Time frame · by the end of 14 successive days of regular use
Registry description
to assess the serum level in both groups

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

3 results

Effect of topical oxytocin gel on vaginal mucosa in postmenopausal Egyptian women: a clinical randomized trial.

Moussa et al. 2023The journal of sexual medicinecited by 4

PMID 36763919DOI 10.1093/jsxmed/qdac021PUB-36763919

Rights unknown3 results

Source link See results (3)

Eligibility

Who could join, as posted.

Sex: Female
Age: from 47 Years up to 66 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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