Vaginal AtrophyNCT03770065
Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women
An observational study of Vaginal Atrophy, run by Viramal Limited at 1 site in United States.
Trial summary
The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- VML-0001
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 8 Apr 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Post-Menopausal women
Who may be able to join
- be greater than 45 years
- no positive findings on screening gynaecological examination
- negative smear test within the last 5 years
Who cannot join
- has signs of vaginal infection
- has evidence of alcohol abuse
- has used hormonal replacement therapy in three months prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Affiliated Research Center, Inc. (MARC)
Huntsville, Alabama, 35801
About this study
Official title: A Phase II, Open-label, Single-Centre, Randomized, Cross-over, Exploratory Study on Two Different Doses of VML-0001, the Base Formulation of Viramal's pH Regulating and Vaginal Moisturizing Cream, on the Effects on Vaginal pH in Healthy Post-Menopausal Women
The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH
- Conditions
- Vaginal Atrophy
- Being tested
- VML-0001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VML-0001Device
Medical device
| Study group | Role | What they receive |
|---|---|---|
| Group A | Not described Receives: Device: VML-0001 | |
| Group B | Not described Receives: Device: VML-0001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.
The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start19 Nov 2018
- Primary completion30 Dec 2019
- Study completion8 Apr 2020
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viramal Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Murray, MD, Principal investigator, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770065
- Sponsor's protocol ID
- VML-0001-003
- Status last verified
- Oct 2020
- First submitted
- 4 Dec 2018
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Single-Centre, Randomized, Cross-over, Exploratory Study on Two Different Doses of VML-0001, the Base Formulation of Viramal's pH Regulating and Vaginal Moisturizing Cream, on the Effects on Vaginal pH in Healthy Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT03770065
- Acronym / sponsor ID
- VML-0001-003
- Conditions
- Vaginal Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Viramal LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 10 Dec 2018 (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 study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: VML-0001 |
| Group B | – | Device: VML-0001 |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Post-Menopausal women
Key inclusion criteria (3 listed)
- be greater than 45 years
- no positive findings on screening gynaecological examination
- negative smear test within the last 5 years
Key exclusion criteria (3 listed)
- has signs of vaginal infection
- has evidence of alcohol abuse
- has used hormonal replacement therapy in three months prior to study entry
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 |
|---|---|---|
| VML-0001Medical device | Device | Group A, Group B |
Primary outcome
To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.
Time frame: 7-14 days
The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.
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 6 Oct 2020.
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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.
James Murray, MD principal investigator
Doctor
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 Vaginal Atrophy, run by Viramal Limited at 1 site in United States.
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 3 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 6 Oct 2020. 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 United States. 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?
To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH. (time frame: 7-14 days). 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 6 Oct 2020.