Vulvovaginal AtrophyPhase 2NCT04222647
Investigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA
A Phase 2 study testing WO533 in people with Vulvovaginal Atrophy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
Trial summary
The aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- WO533
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jan 2020to 11 Aug 2020
- Phase
- Phase 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women with subjective symptomatology of vulvovaginal atrophy
- Signed written informed consent before participation in the trial
Who cannot join
- Known hypersensitivity against any of the ingredients of the investigational product
- Systemic hormonal replacement therapy, or phytohormonal therapy or use of SERMs within 3 months before and / or during the conduct of the trial
- Local hormonal therapy (vagina/vulva) within 3 months before the trial
- If in the opinion of the investigator the patient should not participate in the study for any reason
Trial locations and contacts
1 site in 1 country.
Germany1 site
proDERM Institute for Applied Dermatological Research
Schenefeld
About this study
Official title: Prospective, Open-label, Monocenter, Trial to Investigate the Efficacy and Tolerability of WO533, a Lactic Acid Containing Vaginal Suppository, in a Panel of Post-menopausal Women Suffering From Vulvovaginal Atrophy (VVA)
The aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- WO533
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WO533Drug
Intravaginal application
| Study group | Role | What they receive |
|---|---|---|
| WO533 | Experimental | Formulation containing WO533 for intravaginal application Receives: Drug: WO533 |
What is being measured
The primary outcome is the main question the study is designed to answer.
VMI
Change of the Vaginal Maturation Index (VMI)
Measured: Day 1 to 43
Secondary outcomes (5)
Vaginal pH
Change of vaginal pH
Measured: Day 1 to 8, day 8 to 43, and day 1 to 43
Subjective vulvovaginal atrophy symptoms
Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) and as sum score
Measured: Day 1 to 8, day 8 to 43, and day 1 to 43
Global judgment of the tolerability by the Investigator
Scoring on a scale from 1 to 4
Measured: Day 1 to 43
Global judgment of the tolerability by the patient
Scoring on a scale from 1 to 4
Measured: Day 1 to 43
Adverse events
Measured: Day 1 to 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start27 Jan 2020
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
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 Vulvovaginal 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH, Bremer Pharmacovigilance Service GmbH
- Responsible party
- Sponsor
- Investigators
- Kirstin Deuble-Bente, MD, Principal investigator, proDERM Institute for Applied Dermatological Research, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222647
- Sponsor's protocol ID
- VMP-03/2018
- Other IDs
- 2019-002325-30, 2019
- Status last verified
- Dec 2021
- First submitted
- 9 Oct 2019
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gabes M, Donhauser T, Harder A, Masur C, Apfelbacher CJ. Psychometric evaluation of the German Day-to-Day Impact of Vaginal Aging questionnaire using data from two intervention studies. Menopause. 2023 May 1;30(5):551-555. doi: 10.1097/GME.0000000000002161. Epub 2023 Feb 14.
PubMed 36787527
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label, Monocenter, Trial to Investigate the Efficacy and Tolerability of WO533, a Lactic Acid Containing Vaginal Suppository, in a Panel of Post-menopausal Women Suffering From Vulvovaginal Atrophy (VVA)
- ClinicalTrials.gov ID
- NCT04222647
- Acronym / sponsor ID
- VMP-03/2018
- Conditions
- Vulvovaginal Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH, Bremer Pharmacovigilance Service GmbH
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 10 Jan 2020 (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 aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WO533 | Experimental | Drug: WO533Formulation containing WO533 for intravaginal application |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-menopausal women with subjective symptomatology of vulvovaginal atrophy
- Signed written informed consent before participation in the trial
Key exclusion criteria (4 listed)
- Known hypersensitivity against any of the ingredients of the investigational product
- Systemic hormonal replacement therapy, or phytohormonal therapy or use of SERMs within 3 months before and / or during the conduct of the trial
- Local hormonal therapy (vagina/vulva) within 3 months before the trial
- If in the opinion of the investigator the patient should not participate in the study for any reason
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 |
|---|---|---|
| WO533Intravaginal application | Drug | WO533 |
Primary outcome
VMI
Time frame: Day 1 to 43
Change of the Vaginal Maturation Index (VMI)
5 secondary outcomes
Vaginal pH
Time frame: Day 1 to 8, day 8 to 43, and day 1 to 43
Subjective vulvovaginal atrophy symptoms
Time frame: Day 1 to 8, day 8 to 43, and day 1 to 43
Global judgment of the tolerability by the Investigator
Time frame: Day 1 to 43
Global judgment of the tolerability by the patient
Time frame: Day 1 to 43
Adverse events
Time frame: Day 1 to 43
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 23 Dec 2021.
- Derived from this study: PubMed 36787527Gabes M, Donhauser T, Harder A, Masur C, Apfelbacher CJ. Psychometric evaluation of the German Day-to-Day Impact of Vaginal Aging questionnaire using data from two intervention studies. Menopause. 2023 May 1;30(5):551-555. doi: 10.1097/GME.0000000000002161. Epub 2023 Feb 14.
- 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.
Kirstin Deuble-Bente, MD principal investigator
proDERM Institute for Applied Dermatological Research, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WO533 in people with Vulvovaginal Atrophy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
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 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 23 Dec 2021. 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 Germany. 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.
What does this phase mean?
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?
VMI (time frame: Day 1 to 43). 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 NCT04222647, 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 23 Dec 2021.