Status:
COMPLETED
Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
Lead Sponsor:
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborating Sponsors:
proDERM GmbH
Conditions:
Vaginal Atrophy
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 vag...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT05211505
Start Date
January 31 2022
End Date
March 24 2022
Last Update
April 27 2022
Active Locations (1)
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1
proderm GmbH
Schenefeld, Germany