Vaginal AtrophyPhase 3NCT06514586
The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy
A Phase 3 study testing Oxytocin and Hydroxypropyl methylcellulose in people with Vaginal Atrophy and Genitourinary Syndrome of Menopause, run by Oxagon at 1 site in Egypt.
Trial summary
A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM. Read more about this study
- Who is it for?
- Ages 47 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy, Genitourinary Syndrome of Menopause, Vulvar Atrophy
- What is being tested?
- Oxytocin and Hydroxypropyl methylcellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2024to Aug 2025
- Phase
- Phase 3
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.
- Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and/or dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.
- 4. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH > 5.0 at screening 6. A level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) > 40 milli International Units (mIU)/ml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits
Who cannot join
- Previous treatment with other local non-hormonal moisturizers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion.
- Women taking systemic hormone replacement or pills within the last 6 months.
- Current or history of endometrial hyperplasia or uterine/endometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding
- Any untreated urogenital infection within 14 days prior to randomization.
- Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.
- Critically ill patients.
Show all 9Show fewer
- Patients with severe renal impairment (GFR < 30 ml/min/1.73 m2 as measured by the Cockcroft-Gault formula).
- Patients with known severe hepatic impairment (Child-Pugh C; 10 - 15 points), biliary cirrhosis, or cholestasis.
- Patients with known or suspected allergy or any contraindications to oxytocin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oxagon
Cairo
Ibrahim Gado, 00201094742244, ibrahim.gado@oxagon-ab.com
Khaled Prince, khaled.prince@clinmax.net
About this study
Official title: The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial
A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.
Read the detailed description
A Phase three randomized, double-blinded, placebo- controlled study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM. This study shall include 242 subjects. After screening , subject who meet eligibility criterial will be randomized in a 1:1 ratio to receive wither study intervention or placebo to be applied once daily for sixty days and followed up extra fifteen days. objectives is to evaluate the efficacy and effectiveness of topical oxytocin gel compared with placebo in improving postmenopausal vaginal atrophy symptoms in women with GSM , also assessing the safety and tolerability of topical oxytocin gel.
- Being tested
- Oxytocin, Hydroxypropyl methylcellulose
- Keywords
- vulvovaginal atrophy, postmenopause, vulvovaginal, atrophy
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin gel 600 IU . 1mg/g
Hydroxypropyl methylcelluloseOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MenOxy | Active comparator | The investigational product will contain a Plastic tube containing 36 g of study product (gel) and a Vaginal calibrated plastic applicator for dose (1 ml) administration. The active constituent is oxytocin 600 IU/ml dissolved in a gel based on Hypromellose with a pH of 3.8. Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | The placebo gel will match the IP gel (Hypromellose) with a pH of 3.8, without oxytocin. Receives: Other: Hydroxypropyl methylcellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment.
MBS is a moderate to severe symptom identified as the most bothersome by the subject at baseline, recorded as none, mild, moderate, or severe was analyzed using the score values of 0, 1, 2, or 3, respectively. Symptoms include vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain (dyspareunia), or bleeding associated with sexual activity.
Measured: 60 days
The mean change from the baseline to Day 60 of the vaginal pH
Vaginal pH as measured by a pH strip applied directly to the lateral wall of the vagina, recording the pH value (to one decimal) according to the comparison to the color chart.
Measured: 60 days
The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI)
VMI is calculated using the Meisels'(Meisels, 1967) formula: (0 * Parabasal Cells) + (0.5 * Intermediate Cells) + (1 * Superficial Cells).
Measured: 60 days
Secondary outcomes (12)
The mean changes in MBS severity, pH, and VMI from the baseline to Days 30 and 75
Measured: Days 30 and 75
The percentage of subjects identified as Responders on days 60 and 75.
A responder is a subject meeting all the following criteria: at least 1 point improvement (decrease) in the severity of the MBS, at least a 0.5-point decrease in the vaginal pH, and at least 20% improvement in the VMI.
Measured: Days 60 and 75
The mean change from the baseline to Days 30, 60, and 75 of the physical examination of the vulva and vagina
Assessment of the physical signs of VA (Vaginal secretions, Vaginal Epithelial Integrity, Vaginal Epithelial Surface Thickness, and Vaginal Color) as evaluated by the physician/gynecologist and corresponding to none, mild, moderate, or severe atrophy and analyzed using the score values of 0, 1, 2, and 3, respectively.
Measured: Days 30, 60, and 75
The mean changes from the baseline to Days 30, 60, and 75 in Vaginal Wall Thickness as measured by transvaginal ultrasound.
Measured: Days 30, 60, and 75
The mean changes from the baseline to Days 30, 60, and 75 in Doppler indices measured by transvaginal ultrasound.
Measured: Days 30, 60, and 75
The mean change from the baseline to Days 60 and 75 in selected items from the Female Sexual Function Index (FSFI).
Measured: Days 60, and 75
The mean change from the baseline to Days 60 and 75 in patient-reported psychometric outcomes.
Measured: Days 60 and 75
The number and percentage of subjects on Days 30, 60, and 75 reporting Treatment-Emergent Adverse Event (TEAE), defined as any AE that occurs on or after the application of the first dose of the study intervention.
Measured: Days 30, 60 and 75
The rate of abnormal findings on Days 30, 60, and 75 during the physical, gynecological, and breast examinations.
Measured: Days 30, 60 and 75
The rate of abnormal findings on Days 30, 60, and 75 of the transvaginal ultrasound for women with an intact uterus only.
Measured: Days 30, 60 and 75
The mean medication incompliance rate (%) will be calculated in Days 30, and 60 for each subject as [(Total number of missed doses) / (Expected number of applications)] *100%.
Measured: Days 30,and 60
The incidence of AEs reported by the subjects, summarized by system organ class, severity, and relationship to study intervention, over the course of treatment.
Measured: Days 30, 60 and 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double-Blinded Randomized Controlled Trial The study includes 2 arms. The subjects will be randomized to receive (apply) either oxytocin topical gel (intervention arm) or placebo gel (control arm).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxagon
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Assem Anwar, Principal investigator, Azhar Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514586
- Sponsor's protocol ID
- Oxagon
- Status last verified
- Jul 2024
- First submitted
- 22 Apr 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06514586
- Acronym / sponsor ID
- Oxagon
- Keywords
- vulvovaginal atrophy, postmenopause, vulvovaginal, atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- OxagonResearch network
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.
Detailed description
A Phase three randomized, double-blinded, placebo- controlled study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM. This study shall include 242 subjects. After screening , subject who meet eligibility criterial will be randomized in a 1:1 ratio to receive wither study intervention or placebo to be applied once daily for sixty days and followed up extra fifteen days. objectives is to evaluate the efficacy and effectiveness of topical oxytocin gel compared with placebo in improving postmenopausal vaginal atrophy symptoms in women with GSM , also assessing the safety and tolerability of topical oxytocin gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-Blinded Randomized Controlled Trial The study includes 2 arms. The subjects will be randomized to receive (apply) either oxytocin topical gel (intervention arm) or placebo gel (control arm).
| Arm | Type | Receives |
|---|---|---|
| MenOxy | Active comparator | Drug: OxytocinThe investigational product will contain a Plastic tube containing 36 g of study product (gel) and a Vaginal calibrated plastic applicator for dose (1 ml) administration. The active constituent is oxytocin 600 IU/ml dissolved in a gel based on Hypromellose with a pH of 3.8. |
| Placebo | Placebo comparator | Other: Hydroxypropyl methylcelluloseThe placebo gel will match the IP gel (Hypromellose) with a pH of 3.8, without oxytocin. |
Who may qualify
- Ages
- 47 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.
- Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and/or dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.
- 4. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH > 5.0 at screening 6. A level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) > 40 milli International Units (mIU)/ml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits
Key exclusion criteria (9 listed)
- Previous treatment with other local non-hormonal moisturizers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion.
- Women taking systemic hormone replacement or pills within the last 6 months.
- Current or history of endometrial hyperplasia or uterine/endometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding
- Any untreated urogenital infection within 14 days prior to randomization.
- Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.
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 |
|---|---|---|
| OxytocinOxytocin gel 600 IU . 1mg/g | Drug | MenOxy |
| Hydroxypropyl methylcellulosePlacebo | Other | Placebo |
Primary outcome
The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment.
Time frame: 60 days
MBS is a moderate to severe symptom identified as the most bothersome by the subject at baseline, recorded as none, mild, moderate, or severe was analyzed using the score values of 0, 1, 2, or 3, respectively. Symptoms include vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain (dyspareunia), or bleeding associated with sexual activity.
The mean change from the baseline to Day 60 of the vaginal pH
Time frame: 60 days
Vaginal pH as measured by a pH strip applied directly to the lateral wall of the vagina, recording the pH value (to one decimal) according to the comparison to the color chart.
The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI)
Time frame: 60 days
VMI is calculated using the Meisels'(Meisels, 1967) formula: (0 * Parabasal Cells) + (0.5 * Intermediate Cells) + (1 * Superficial Cells).
12 secondary outcomes
The mean changes in MBS severity, pH, and VMI from the baseline to Days 30 and 75
Time frame: Days 30 and 75
The percentage of subjects identified as Responders on days 60 and 75.
Time frame: Days 60 and 75
The mean change from the baseline to Days 30, 60, and 75 of the physical examination of the vulva and vagina
Time frame: Days 30, 60, and 75
The mean changes from the baseline to Days 30, 60, and 75 in Vaginal Wall Thickness as measured by transvaginal ultrasound.
Time frame: Days 30, 60, and 75
The mean changes from the baseline to Days 30, 60, and 75 in Doppler indices measured by transvaginal ultrasound.
Time frame: Days 30, 60, and 75
The mean change from the baseline to Days 60 and 75 in selected items from the Female Sexual Function Index (FSFI).
Time frame: Days 60, and 75
The mean change from the baseline to Days 60 and 75 in patient-reported psychometric outcomes.
Time frame: Days 60 and 75
The number and percentage of subjects on Days 30, 60, and 75 reporting Treatment-Emergent Adverse Event (TEAE), defined as any AE that occurs on or after the application of the first dose of the study intervention.
Time frame: Days 30, 60 and 75
The rate of abnormal findings on Days 30, 60, and 75 during the physical, gynecological, and breast examinations.
Time frame: Days 30, 60 and 75
The rate of abnormal findings on Days 30, 60, and 75 of the transvaginal ultrasound for women with an intact uterus only.
Time frame: Days 30, 60 and 75
The mean medication incompliance rate (%) will be calculated in Days 30, and 60 for each subject as [(Total number of missed doses) / (Expected number of applications)] *100%.
Time frame: Days 30,and 60
The incidence of AEs reported by the subjects, summarized by system organ class, severity, and relationship to study intervention, over the course of treatment.
Time frame: Days 30, 60 and 75
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Assem Anwar principal investigator
Azhar Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxytocin and Hydroxypropyl methylcellulose in people with Vaginal Atrophy and Genitourinary Syndrome of Menopause, run by Oxagon 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Gado (00201094742244, ibrahim.gado@oxagon-ab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment. (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.