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

Vaginal Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211505
• Other study ID #: VFCrC-01/2021
• Status: Completed
• Phase: Phase 4
• Start date: January 31, 2022
• Est. completion date: March 24, 2022

Study information

• Verified date: April 2022
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Natural cessation of last menstruation more than 12 months before screening OR bilateral oophorectomy with or without hysterectomy more than 3 months before screening

3. Signed written informed consent before participation in the clinical investigation

Exclusion Criteria:

1. Vaginal inflammation which is not caused by vulvovaginal atrophy

2. Non-healed vaginal surgery

3. 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

4. Local hormonal therapy (vagina/vulva) within 3 months before Screening (also when used for the brightening/pretreatment of cytological smears)

5. 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)

6. Systemic corticosteroids within 21 days before visit 1 (day 1) and during the conduct of this clinical investigation (corticoid asthma sprays are allowed)

7. 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

8. Known hypersensitivity against any of the ingredients of the investigational medical device

9. Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

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

Locations

Country	Name	City	State
Germany	proderm GmbH	Schenefeld

Sponsors (2)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	proDERM GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From baseline to visit 3 (day 38)
Secondary	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).	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)
Secondary	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	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)
Secondary	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).	From baseline to visit 3 (day 38)
Secondary	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).	From baseline to visit 3 (day 38)
Secondary	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)	From baseline to visit 3 (day 38)
Secondary	Change of vaginal pH		From baseline to visit 3 (day 38)
Secondary	Patient questionnaire		Day 3, visit 3 (day 38), visit 4 (day 44)
Secondary	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	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)
Secondary	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).	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)
Secondary	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	On visit 3 (day 38)
Secondary	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	On visit 3 (day 38)
Secondary	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	On visit 3 (day 38)
Secondary	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	On visit 3 (day 38)
Secondary	Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication		From baseline to visit 4 (day 44)