Skip to main content
OpenTrials
Completed

NCT Number: NCT05211505

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaginal Atrophy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

proderm GmbH

Schenefeld, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

WO 2707

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

    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).

  2. 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)

    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

  3. 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)

    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).

  4. 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)

    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).

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

    Time frame: From baseline to visit 3 (day 38)

    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)

  6. Change of vaginal pH

    Time frame: From baseline to visit 3 (day 38)

  7. Patient questionnaire

    Time frame: Day 3, visit 3 (day 38), visit 4 (day 44)

  8. 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)

    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

  9. 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)

    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).

  10. Global judgement of efficacy by the investigator

    Time frame: On visit 3 (day 38)

    The global judgement of efficacy will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor

  11. Global judgement of efficacy by the patient

    Time frame: On visit 3 (day 38)

    The global judgement of efficacy will be assessed according to the following scale: 1=very good,2=good, 3=moderate, 4=poor

  12. Global judgement of tolerability by the investigator

    Time frame: On visit 3 (day 38)

    The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor

  13. Global judgement of tolerability by the patient

    Time frame: On visit 3 (day 38)

    The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate,4=poor

  14. Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication

    Time frame: From baseline to visit 4 (day 44)

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Collaborators

  • proDERM GmbH

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.