Genitourinary Syndrome of MenopausePhase 1/2NCT05453227
Zinc Containing Vaginal Topical " Suppository "
A Phase 1/2 study testing Zinc in people with Genitourinary Syndrome of Menopause, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal symptoms and signs associated with physical changes of the vulva, vagina, and lower urinary tract. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Zinc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 30 Dec 2022
- Phase
- Phase 1/2
- 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 55 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of symptoms of vulvovaginal atrophy/GSM in postmenopausal women. including vaginal dryness, burning, itching, vagina pain and dyspareunia. To be defined as a postmenopausal woman.
- individuals had to have at least 12 consecutive months of amenorrhea without any other obvious reason/or consistently elevated follicle-stimulating hormone blood levels of 30 mIU/mL or higher.
Who cannot join
- premenopausal state,
- local or systemic hormone therapy within the past six months
- vaginal infection at presentation
- cytological atypia
- prior radiation treatment
- history of breast, ovarian or other gynecological cancer
- pelvic organ prolapse > stage 2
- recent use (3 months) of any vaginal product or douching.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Azhar University Hospitals and Ashmoun central hospital
Cairo, Elmenofia
About this study
Official title: Zinc Containing Vaginal Topical " Suppository " in Improving Post Menopausal Genitourinary Syndrome: "Double Blind Controlled Study "
The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal symptoms and signs associated with physical changes of the vulva, vagina, and lower urinary tract.
The GSM includes not only genital symptoms (dryness, burning, and irritation) and sexual symptoms (lack of lubrication, discomfort or pain, and impaired function), but also urinary symptoms (urgency, dysuria, and recurrent urinary tract infections [UTI])
Read the detailed description
The terms vulvovaginal atrophy and atrophic vaginitis were widely used until recently, but they have been considered to be inadequate for referring to the constellation of symptoms and signs associated with the genitourinary system after menopause.
The term vulvovaginal atrophy mentions the vulva and vagina only, and these words are not used comfortably in general social discussion and in the media. The term atrophic vaginitis implies a state of inflammation or infection, which is not a primary component of menopausal changes. In addition, a limitation of the terms vulvovaginal atrophy and atrophic vaginitis is that they do not take into account the symptoms of the lower urinary tract, which are among the most important symptoms related to menopause.
Vulvovaginal atrophy (VVA) is a prevalent condition affecting many postmenopausal women.1 Up to 40% of postmenopausal women develop symptoms of VVA.
It is most often diagnosed by its symptoms, including vaginal dryness, burning, itching, vagina pain and dyspareunia. More recently these symptoms have been described as a syndrome: the genitourinary syndrome of menopause (GSM).
This new term describes various menopausal symptoms and signs including not only genital symptoms but sexual (pain) and urinary symptoms (dysuria, urgency) as well.
The pathophysiology of GSM/VVA can be explained by the decline in estrogen levels associated with diminished ovarian function and natural aging.
Traditionally the treatment options for GSM/VVA was vaginal estrogen supplementation but many women are either unable to or are afraid to use hormones. There are several non-hormonal treatment modalities for the management of VVA related symptoms, especially for one of the most bothersome symptoms of vaginal dryness.
The 2013 position statement of The North American Menopause Society indicates that the first-line therapies to alleviate symptoms of VVA should include non-hormonal vaginal lubricants and moisturizers as well as regular sexual activity.
Although there are numerous vaginal moisturizers and lubricants are commercially available only a few of those have been tested in clinical trials.
Previously the investigators showed the role of vaginal zinc supplementation on vaginal remodeling. The investigators showed that in human vaginal smooth muscle cells, zinc has a beneficial effect on the production of extracellular components produced by the muscle at 20 μM zinc tissue level, thereby increasing the amount of elastin production.
Earlier animal studies have shown that zinc plays an important role in the vaginal extracellular matrix (ECM) composition. When rats were kept on a zinc-lacking diet, the vaginal structure became similar to the menopausal vagina.With vaginal zinc replacement, the vaginal ECM could be regenerated with characteristics equivalent to juvenile rats .
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Zinc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDrug
To test the effect of a novel zinc-containing vaginal topical on GSM/VVA symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Zinc Group | Active comparator | 25 cases will be undergo treatment with active ingredient Receives: Drug: Zinc |
| Plcebo Group | Placebo comparator | 25 cases will be undergo treatment with placebo Receives: Drug: Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
The using of novel zinc-containing vaginal suppositories
Assessment of postmenopausal symptoms as dryness, burning, and irritation by Vaginal Health Index (VHI) score: elasticity, fluid secretion, pH and epithelial mucosa (integrity) and moisture components. Each component is scored on a scale of 1 (worst) to 5 (best). Lower scores indicate more severe atrophy. VHI was calculated at baseline and 2 weeks after the treatment.
Measured: From baseline to 2 weeks after using the zinc sulphate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2022
- Study completion30 Dec 2022
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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Assem Anwar, Professor, Study chair, Department of Obstetrics & Gynecology Faculty of Medicine for boys, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453227
- Sponsor's protocol ID
- Bahaa Mohamed
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2022
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Containing Vaginal Topical " Suppository " in Improving Post Menopausal Genitourinary Syndrome: "Double Blind Controlled Study "
- ClinicalTrials.gov ID
- NCT05453227
- Acronym / sponsor ID
- Bahaa Mohamed
- Conditions
- Genitourinary Syndrome of Menopause
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 12 Jul 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.
The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal symptoms and signs associated with physical changes of the vulva, vagina, and lower urinary tract.
The GSM includes not only genital symptoms (dryness, burning, and irritation) and sexual symptoms (lack of lubrication, discomfort or pain, and impaired function), but also urinary symptoms (urgency, dysuria, and recurrent urinary tract infections [UTI])
Detailed description
The terms vulvovaginal atrophy and atrophic vaginitis were widely used until recently, but they have been considered to be inadequate for referring to the constellation of symptoms and signs associated with the genitourinary system after menopause.
The term vulvovaginal atrophy mentions the vulva and vagina only, and these words are not used comfortably in general social discussion and in the media. The term atrophic vaginitis implies a state of inflammation or infection, which is not a primary component of menopausal changes. In addition, a limitation of the terms vulvovaginal atrophy and atrophic vaginitis is that they do not take into account the symptoms of the lower urinary tract, which are among the most important symptoms related to menopause.
Vulvovaginal atrophy (VVA) is a prevalent condition affecting many postmenopausal women.1 Up to 40% of postmenopausal women develop symptoms of VVA.
It is most often diagnosed by its symptoms, including vaginal dryness, burning, itching, vagina pain and dyspareunia. More recently these symptoms have been described as a syndrome: the genitourinary syndrome of menopause (GSM).
This new term describes various menopausal symptoms and signs including not only genital symptoms but sexual (pain) and urinary symptoms (dysuria, urgency) as well.
The pathophysiology of GSM/VVA can be explained by the decline in estrogen levels associated with diminished ovarian function and natural aging.
Traditionally the treatment options for GSM/VVA was vaginal estrogen supplementation but many women are either unable to or are afraid to use hormones. There are several non-hormonal treatment modalities for the management of VVA related symptoms, especially for one of the most bothersome symptoms of vaginal dryness.
The 2013 position statement of The North American Menopause Society indicates that the first-line therapies to alleviate symptoms of VVA should include non-hormonal vaginal lubricants and moisturizers as well as regular sexual activity.
Although there are numerous vaginal moisturizers and lubricants are commercially available only a few of those have been tested in clinical trials.
Previously the investigators showed the role of vaginal zinc supplementation on vaginal remodeling. The investigators showed that in human vaginal smooth muscle cells, zinc has a beneficial effect on the production of extracellular components produced by the muscle at 20 μM zinc tissue level, thereby increasing the amount of elastin production.
Earlier animal studies have shown that zinc plays an important role in the vaginal extracellular matrix (ECM) composition. When rats were kept on a zinc-lacking diet, the vaginal structure became similar to the menopausal vagina.With vaginal zinc replacement, the vaginal ECM could be regenerated with characteristics equivalent to juvenile rats .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc Group | Active comparator | Drug: Zinc25 cases will be undergo treatment with active ingredient |
| Plcebo Group | Placebo comparator | Drug: Zinc25 cases will be undergo treatment with placebo |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of symptoms of vulvovaginal atrophy/GSM in postmenopausal women. including vaginal dryness, burning, itching, vagina pain and dyspareunia. To be defined as a postmenopausal woman.
- individuals had to have at least 12 consecutive months of amenorrhea without any other obvious reason/or consistently elevated follicle-stimulating hormone blood levels of 30 mIU/mL or higher.
Key exclusion criteria (8 listed)
- premenopausal state,
- local or systemic hormone therapy within the past six months
- vaginal infection at presentation
- cytological atypia
- prior radiation treatment
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 |
|---|---|---|
| ZincTo test the effect of a novel zinc-containing vaginal topical on GSM/VVA symptoms. | Drug | Plcebo Group, Zinc Group |
Primary outcome
The using of novel zinc-containing vaginal suppositories
Time frame: From baseline to 2 weeks after using the zinc sulphate
Assessment of postmenopausal symptoms as dryness, burning, and irritation by Vaginal Health Index (VHI) score: elasticity, fluid secretion, pH and epithelial mucosa (integrity) and moisture components. Each component is scored on a scale of 1 (worst) to 5 (best). Lower scores indicate more severe atrophy. VHI was calculated at baseline and 2 weeks after the treatment.
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 17 Oct 2023.
- 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, Professor study chair
Department of Obstetrics & Gynecology Faculty of Medicine for boys, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zinc in people with Genitourinary Syndrome of Menopause, run by Egymedicalpedia 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 2 inclusion and 8 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 17 Oct 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The using of novel zinc-containing vaginal suppositories (time frame: From baseline to 2 weeks after using the zinc sulphate). 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 17 Oct 2023.