Clinical trial NCT05211505: Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Atrophy
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: proDERM GmbH
First posted: 2022-01-27
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 vaginal dryness.


Eligibility criteria: 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

Primary outcomes:
measure: Change of TSS (Total severity score) for subjective symptoms of atrophy
timeFrame: From baseline to visit 3 (day 38)
Secondary outcomes:
measure: Change of TSS (Total severity score) for subjective symptoms of atrophy
timeFrame: 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)
measure: Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse)
timeFrame: 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)
measure: Change of each DIVA domain score (A - D) and change of total DIVA score (excluding questions 12 to 15)
timeFrame: From baseline to visit 3 (day 38)
measure: Change of each DIVA domain score (A - D) and change of total DIVA score in the subgroup of sexually active women with dyspareunia
timeFrame: From baseline to visit 3 (day 38)
measure: Change of each single parameter and of sum score over objective assessment of VHI
timeFrame: From baseline to visit 3 (day 38)
measure: Change of vaginal pH
timeFrame: From baseline to visit 3 (day 38)
measure: Patient questionnaire
timeFrame: Day 3, visit 3 (day 38), visit 4 (day 44)
measure: Change of severity scoring for dyspareunia for the subgroup of sexually active women with dyspareunia
timeFrame: 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)
measure: Change of impairment of daily life due to dyspareunia (VAS) for the subgroup of sexually active women with dyspareunia
timeFrame: 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)
measure: Global judgement of efficacy by the investigator
timeFrame: On visit 3 (day 38)
measure: Global judgement of efficacy by the patient
timeFrame: On visit 3 (day 38)
measure: Global judgement of tolerability by the investigator
timeFrame: On visit 3 (day 38)
measure: Global judgement of tolerability by the patient
timeFrame: On visit 3 (day 38)
measure: Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication
timeFrame: From baseline to visit 4 (day 44)
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: proderm GmbH
Study officials:
affiliation: proderm GmbH, Germany
name: Kirstin Deuble-Bente, MD
role: PRINCIPAL_INVESTIGATOR
References: