Genitourinary Syndrome of MenopauseNCT05871255
Natural Topical Treatment for Vulvar and Vaginal Atrophy
An observational study of Genitourinary Syndrome of Menopause, run by Dr. Amjad Khan at 1 site in Italy.
Trial summary
Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Zantogin® Gel
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jan 2022to 30 Apr 2023
- Phase
- Observational
- 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 45 to 65 years
- Women only
- Adult, Older adult
Study population: Same as the inclusion/exclusion criteria
Who may be able to join
- Age between 45-65 years
- Menopause and symptomatic vulvovaginal atrophy (VVA) (vaginal dryness, dyspareunia, vaginal irritation, vaginal itching, dysuria)
- No previous treatment for VVA
- Informed written consent signed
Who cannot join
- Pregnancy
- Previous or concurrent neoplasms
- Uncompensated concomitant diseases (i.e., diabetes, cardiac diseases)
- Previous or concurrent Hormone replacement therapy (HRT) or radiotherapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural Topical Treatment for Vulvar and Vaginal Atrophy: a Single-center Prospective Observational Study
Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.
Read the detailed description
The aim of this prospective observational study is to evaluate safety and efficacy of Zantogin® Gel (ZG) a class II medical device developed for intravaginal use in the treatment of signs and symptoms of post-menopausal vulvovaginal atrophy (VVA), in terms of improvement of objective parameters assessing vaginal health (Vaginal Health Index score) and subsequent patients' sexual quality of life (Female Sexual Distress Scale).
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Zantogin® Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zantogin® GelOther
Zantogin® Gel (ZG) is a multicomponent vaginal lubricant endowed with lenitive and anti-inflammatory properties, developed as class II medical device for the treatment of VVA.
| Study group | Role | What they receive |
|---|---|---|
| Genitourinary syndrome of menopause (GSM) patients | Patients will apply the vaginal gel (ZG) for a total of 150 days of treatment. The application was daily for the first 12 days, then every 48 hours until the end of the study. Patients will be examined at baseline (T0), after 12 (T1), 57 (T2) and 150 (T3) days of treatment. Examination will include (1) Filling of a Female Sexual Distress Scale (FSDS) questionnaire and (2) Gynecology examination with colposcopy and pH test to evaluate vaginal elasticity, vaginal secretions, pH, mucosal epithelium, and vaginal hydration to calculate the Vaginal Health Index (VHI). Receives: Other: Zantogin® Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vaginal health index score
Scale score range is 5-25. The minimum 5 points core indicates severe vulvovaginal atrophy and the maximum total score of 25 points indicates no clinical signs of vulvovaginal atrophy.
Measured: 5.5 months
Change in Female Sexual Distress Scale (FSD)
A score of ≥11 effectively discriminates between women with FSD and no FSD.
Measured: 5.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start5 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Amjad Khan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Sponsor-investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871255
- Sponsor's protocol ID
- 6407
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Topical Treatment for Vulvar and Vaginal Atrophy: a Single-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05871255
- Acronym / sponsor ID
- 6407
- Conditions
- Genitourinary Syndrome of Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. Amjad KhanUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 23 May 2023 (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.
Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.
Detailed description
The aim of this prospective observational study is to evaluate safety and efficacy of Zantogin® Gel (ZG) a class II medical device developed for intravaginal use in the treatment of signs and symptoms of post-menopausal vulvovaginal atrophy (VVA), in terms of improvement of objective parameters assessing vaginal health (Vaginal Health Index score) and subsequent patients' sexual quality of life (Female Sexual Distress Scale).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genitourinary syndrome of menopause (GSM) patients | – | Other: Zantogin® GelPatients will apply the vaginal gel (ZG) for a total of 150 days of treatment. The application was daily for the first 12 days, then every 48 hours until the end of the study. Patients will be examined at baseline (T0), after 12 (T1), 57 (T2) and 150 (T3) days of treatment. Examination will include (1) Filling of a Female Sexual Distress Scale (FSDS) questionnaire and (2) Gynecology examination with colposcopy and pH test to evaluate vaginal elasticity, vaginal secretions, pH, mucosal epithelium, and vaginal hydration to calculate the Vaginal Health Index (VHI). |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Same as the inclusion/exclusion criteria
Key inclusion criteria (4 listed)
- Age between 45-65 years
- Menopause and symptomatic vulvovaginal atrophy (VVA) (vaginal dryness, dyspareunia, vaginal irritation, vaginal itching, dysuria)
- No previous treatment for VVA
- Informed written consent signed
Key exclusion criteria (4 listed)
- Pregnancy
- Previous or concurrent neoplasms
- Uncompensated concomitant diseases (i.e., diabetes, cardiac diseases)
- Previous or concurrent Hormone replacement therapy (HRT) or radiotherapy or chemotherapy.
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 |
|---|---|---|
| Zantogin® GelZantogin® Gel (ZG) is a multicomponent vaginal lubricant endowed with lenitive and anti-inflammatory properties, developed as class II medical device for the treatment of VVA. | Other | Genitourinary syndrome of menopause (GSM) patients |
Primary outcome
Change in vaginal health index score
Time frame: 5.5 months
Scale score range is 5-25. The minimum 5 points core indicates severe vulvovaginal atrophy and the maximum total score of 25 points indicates no clinical signs of vulvovaginal atrophy.
Change in Female Sexual Distress Scale (FSD)
Time frame: 5.5 months
A score of ≥11 effectively discriminates between women with FSD and no FSD.
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 13 Nov 2023.
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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?
An observational study of Genitourinary Syndrome of Menopause, run by Dr. Amjad Khan at 1 site in Italy.
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 4 inclusion and 4 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 13 Nov 2023. 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 Italy. 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. 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?
Change in vaginal health index score (time frame: 5.5 months). The study lists 2 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 13 Nov 2023.