Vaginal AtrophyPhase 4NCT05211505

Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness

A Phase 4 study testing WO 2707 in people with Vaginal Atrophy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the clinical investigation is to evaluate the efficacy and tolerability of WO 2707, a MoistCream Cremolum, with respect to the application in postmenopausal women with symptoms of vaginal dryness. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Vaginal Atrophy
What is being tested?: WO 2707
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteGermany
Study dates: 31 Jan 2022to 24 Mar 2022
Phase: Phase 4
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Post-menopausal women with the subjective symptomatology of vulvovaginal atrophy with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a score of at least "2" (moderate) for the parameter dryness at screening and visit 1 (day 1)
Thereof at least for 48 included patients: sexual activity with dyspareunia
Thereof at least 32 included sexually active patients with at least moderate (score of "2") dyspareunia
Natural cessation of last menstruation more than 12 months before screening OR bilateral oophorectomy with or without hysterectomy more than 3 months before screening
Signed written informed consent before participation in the clinical investigation

Who cannot join

Vaginal inflammation which is not caused by vulvovaginal atrophy
Non-healed vaginal surgery
Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (selective estrogen receptor modulators) within 3 months before visit 1 (day 1) and / or during the conduct of this clinical investigation
Local hormonal therapy (vagina/vulva) within 3 months before Screening (also when used for the brightening/pretreatment of cytological smears)
Any use of products (including lubricants), other than the investigational medicinal device, applied intravaginally or on the vulva during the clinical investigation (except usual cleansing products)
Systemic corticosteroids within 21 days before visit 1 (day 1) and during the conduct of this clinical investigation (corticoid asthma sprays are allowed)

Show all 9Show fewer

Use of antibiotics, antiseptics or antimycotics with expected or suspected systemic or vaginal/vulvar bioavailability within 21 days before visit 1 (day 1) and / or during this clinical investigation
Known hypersensitivity against any of the ingredients of the investigational medical device
Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company

Trial locations and contacts

1 site in 1 country.

Germany1 site

proderm GmbH
Schenefeld

Other trials in Germany

About this study

Official title: Prospective, Open-label Trial Investigating the Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness

Conditions: Vaginal Atrophy
Being tested: WO 2707

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WO 2707Device
Intravaginal application once daily for 1 week, then twice per week until visit 3 (day 38).

Study groups in NCT05211505
Study group	Role	What they receive
WO 2707	Experimental	Formulation containing WO 2707 for intravaginal application Receives: Device: WO 2707

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of TSS (Total severity score) for subjective symptoms of atrophy
The severity of each of the subjective symptoms dryness, itching, burning and pain unrelated to sexual intercourse will be assessed according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
The total severity score will be calculated as the sum score of the subjective symptoms resulting in a minimum score of 0 (best) and a maximal score of 16 (worst).
Measured: From baseline to visit 3 (day 38)

Secondary outcomes (14)

Change of TSS (Total severity score) for subjective symptoms of atrophy
The severity of each of the subjective symptoms dryness, itching, burning and pain unrelated to sexual intercourse will be assessed according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
The total severity score will be calculated as the sum score of the subjective symptoms resulting in a minimum score of 0 (best) and a maximal score of 16 (worst).
Measured: From baseline to visit 2 (day 8), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44)
Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse)
The severity of each of the subjective symptoms dryness, itching, burning and pain unrelated to sexual intercourse will be assessed according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Measured: From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44)
Change of each DIVA domain score (A - D) and change of total DIVA score (excluding questions 12 to 15)
The DIVA questionnaire addresses the impact of vaginal symptoms such as vaginal dryness, soreness, irritation and itching on the day-to-day life regarding the patient's activities, relationships, and feelings by any of these symptoms (Huang, 2015; Gabes, 2021).
Measured: From baseline to visit 3 (day 38)
Change of each DIVA domain score (A - D) and change of total DIVA score in the subgroup of sexually active women with dyspareunia
The DIVA questionnaire addresses the impact of vaginal symptoms such as vaginal dryness, soreness, irritation and itching on the day-to-day life regarding the patient's activities, relationships, and feelings by any of these symptoms (Huang, 2015; Gabes, 2021).
Measured: From baseline to visit 3 (day 38)
Change of each single parameter and of sum score over objective assessment of VHI
The objective status of the vagina will be assessed by the Investigator according to the Vaginal Health Index (Bachmann, 1995). Each of the five criteria - elasticity, fluid secretion, pH, epithelial mucosa and moisture - will be graded from 1 (worst) to 5 (best) and will then be summed up, so that the minimum score will be 5 (worst) and the maximum score will be 25 (best)
Measured: From baseline to visit 3 (day 38)
Change of vaginal pH
Measured: From baseline to visit 3 (day 38)
Patient questionnaire
Measured: Day 3, visit 3 (day 38), visit 4 (day 44)
Change of severity scoring for dyspareunia for the subgroup of sexually active women with dyspareunia
Severity scoring for Dyspareunia will be assessed by the patients according to the following scale: 0=none,1=mild, 2=moderate, 3=severe, 4=very severe
Measured: From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44)
Change of impairment of daily life due to dyspareunia (VAS) for the subgroup of sexually active women with dyspareunia
Impairment of daily life due to dyspareunia will be assessed using a 10 cm visual analogue scale (VAS) ranging from 0 (no impairment) to 10 (very pronounced impairment).
Measured: From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44)
Global judgement of efficacy by the investigator
The global judgement of efficacy will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor
Measured: On visit 3 (day 38)
Global judgement of efficacy by the patient
The global judgement of efficacy will be assessed according to the following scale: 1=very good,2=good, 3=moderate, 4=poor
Measured: On visit 3 (day 38)
Global judgement of tolerability by the investigator
The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor
Measured: On visit 3 (day 38)
Global judgement of tolerability by the patient
The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate,4=poor
Measured: On visit 3 (day 38)
Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication
Measured: From baseline to visit 4 (day 44)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202224 Mar 2022

First posted27 Jan 2022
Study start31 Jan 2022
Primary completion24 Mar 2022
Study completion24 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05211505
Sponsor's protocol ID: VFCrC-01/2021
Status last verified: Apr 2022
First submitted: 13 Jan 2022
Last updated: 27 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Eichler S, Panz M, Harder A, Masur C, Hauser M, Wiesche ESZ. An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause. Maturitas. 2024 Jul;185:107978. doi: 10.1016/j.maturitas.2024.107978. Epub 2024 Mar 29.
PubMed 38583316
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms

All Vaginal Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Open-label Trial Investigating the Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
ClinicalTrials.gov ID: NCT05211505
Acronym / sponsor ID: VFCrC-01/2021
Conditions: Vaginal Atrophy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
Collaborators: proDERM GmbH
Study start: 31 Jan 2022 (actual)
Primary completion: 24 Mar 2022 (actual)
Study completion: 24 Mar 2022 (actual)
First posted: 27 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
WO 2707	Experimental	Device: WO 2707Formulation containing WO 2707 for intravaginal application

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Post-menopausal women with the subjective symptomatology of vulvovaginal atrophy with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a score of at least "2" (moderate) for the parameter dryness at screening and visit 1 (day 1)
Natural cessation of last menstruation more than 12 months before screening OR bilateral oophorectomy with or without hysterectomy more than 3 months before screening
Signed written informed consent before participation in the clinical investigation

Key exclusion criteria (9 listed)

Vaginal inflammation which is not caused by vulvovaginal atrophy
Non-healed vaginal surgery
Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (selective estrogen receptor modulators) within 3 months before visit 1 (day 1) and / or during the conduct of this clinical investigation
Local hormonal therapy (vagina/vulva) within 3 months before Screening (also when used for the brightening/pretreatment of cytological smears)
Any use of products (including lubricants), other than the investigational medicinal device, applied intravaginally or on the vulva during the clinical investigation (except usual cleansing products)

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
WO 2707Intravaginal application once daily for 1 week, then twice per week until visit 3 (day 38).	Device	WO 2707

Primary outcome

Change of TSS (Total severity score) for subjective symptoms of atrophy
Time frame: From baseline to visit 3 (day 38)
The severity of each of the subjective symptoms dryness, itching, burning and pain unrelated to sexual intercourse will be assessed according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe The total severity score will be calculated as the sum score of the subjective symptoms resulting in a minimum score of 0 (best) and a maximal score of 16 (worst).

14 secondary outcomes

Change of TSS (Total severity score) for subjective symptoms of atrophy
Time frame: From baseline to visit 2 (day 8), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44)
Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse)
Time frame: From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44)
Change of each DIVA domain score (A - D) and change of total DIVA score (excluding questions 12 to 15)
Time frame: From baseline to visit 3 (day 38)
Change of each DIVA domain score (A - D) and change of total DIVA score in the subgroup of sexually active women with dyspareunia
Time frame: From baseline to visit 3 (day 38)
Change of each single parameter and of sum score over objective assessment of VHI
Time frame: From baseline to visit 3 (day 38)
Change of vaginal pH
Time frame: From baseline to visit 3 (day 38)
Patient questionnaire
Time frame: Day 3, visit 3 (day 38), visit 4 (day 44)
Change of severity scoring for dyspareunia for the subgroup of sexually active women with dyspareunia
Time frame: From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44)
Change of impairment of daily life due to dyspareunia (VAS) for the subgroup of sexually active women with dyspareunia
Time frame: From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44)
Global judgement of efficacy by the investigator
Time frame: On visit 3 (day 38)
Global judgement of efficacy by the patient
Time frame: On visit 3 (day 38)
Global judgement of tolerability by the investigator
Time frame: On visit 3 (day 38)
Global judgement of tolerability by the patient
Time frame: On visit 3 (day 38)
Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication
Time frame: From baseline to visit 4 (day 44)

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 27 Apr 2022.
Derived from this study: PubMed 38583316Eichler S, Panz M, Harder A, Masur C, Hauser M, Wiesche ESZ. An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause. Maturitas. 2024 Jul;185:107978. doi: 10.1016/j.maturitas.2024.107978. Epub 2024 Mar 29.
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

Related trials for Vaginal Atrophy

RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms

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 GmbH, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing WO 2707 in people with Vaginal 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 5 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: finished, as of the sponsor's last update on 27 Apr 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Change of TSS (Total severity score) for subjective symptoms of atrophy (time frame: From baseline to visit 3 (day 38)). 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 NCT05211505, which also lists 2 linked publications.

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 27 Apr 2022.