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

NCT05211505 | Completed Phase 4

• 1 other identifier: VFCrC-01/2021
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change of TSS (Total severity score) for subjective symptoms of atrophy

  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)

  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)

  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

  From baseline to visit 3 (day 38)

• Change of each single parameter and of sum score over objective assessment of VHI

  From baseline to visit 3 (day 38)

Study Arms (1)

WO 2707

EXPERIMENTAL

Formulation containing WO 2707 for intravaginal application

Device: WO 2707

Interventions

WO 2707 DEVICE

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

WO 2707

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead
• proDERM GmbH: collaborator

Study Sites (1)

proderm GmbH

Schenefeld, Germany

Location

Related Publications (2)

• 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.

  PMID: 38583316 DERIVED

• 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.

  PMID: 36787527 DERIVED

Study Officials

• Kirstin Deuble-Bente, MD

  proderm GmbH, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: January 31, 2022
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)