Menopause Related ConditionsNCT05275270
Role of Topical Oxytocin Gel in Post-Menopausal Women
A study testing oxytocin gel in people with Menopause Related Conditions, run by Al-Azhar University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 47 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Related Conditions
- What is being tested?
- oxytocin gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Topical Oxytocin Gel On Vaginal Atrophy, Psycho-sexual and Psychological Function and Metabolic and Inflammatory Parameters in Post-Menopausal Egyptian Women
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
- Conditions
- Menopause Related Conditions
- Being tested
- oxytocin gel, placebo gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients were treated with an active gel containing oxytocin Receives: Other: oxytocin gel |
| Group B | Placebo comparator | patients were treated with placebo gel without oxytocin Receives: Other: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal pallor
A vaginal inspection was performed to establish the presence of vaginal pallor
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: by the end of 14 successive days of regular use
Cholesterol
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
Triglyceride
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
HDL-C
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
LDL-C
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
C-Reactive Protein (CRP)
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
Random blood sugar (RBS)
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
HBA1C
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
Insulin
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
C-Peptide F
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
Cortisol at morning
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
Interleukin-6 (IL-6)
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
Tumor necrosis factor-Alfa (TNF-Alfa)
to assess the serum level in both groups
Measured: by the end of 14 successive days of regular use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Dec 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Principal investigator, Asem Anwar Moussa, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275270
- Sponsor's protocol ID
- Topical Oxytocin Gel
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36763919
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Topical Oxytocin Gel On Vaginal Atrophy, Psycho-sexual and Psychological Function and Metabolic and Inflammatory Parameters in Post-Menopausal Egyptian Women
- ClinicalTrials.gov ID
- NCT05275270
- Acronym / sponsor ID
- Topical Oxytocin Gel
- Conditions
- Menopause Related Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: oxytocin gelpatients were treated with an active gel containing oxytocin |
| Group B | Placebo comparator | Other: placebo gelpatients were treated with placebo gel without oxytocin |
Who may qualify
- Ages
- 47 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxytocin gelThe 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 | Other | Group A |
| placebo gelThe placebo gel (B) consisted of the gel alone | Other | Group B |
Primary outcome
vaginal pallor
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
Triglyceride
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
HDL-C
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
LDL-C
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
C-Reactive Protein (CRP)
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
Random blood sugar (RBS)
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
HBA1C
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
Insulin
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
C-Peptide F
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
Cortisol at morning
Time frame: by the end of 14 successive days of regular use
to assess the serum level in both groups
Interleukin-6 (IL-6)
Time frame: by the end of 14 successive days of regular use
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
to assess the serum level in both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 36763919Moussa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxytocin gel in people with Menopause Related Conditions, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal pallor (time frame: by the end of 14 successive days of regular use). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.