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Investigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA

Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel (Industry)
Overall Status
Completed
CT.gov ID
NCT04222647
Collaborator
proDERM Institut für Angewandte Dermatologische Forschung GmbH (Other), Bremer Pharmacovigilance Service GmbH (Other)
43
Enrollment
1
Location
1
Arm
6.5
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective, Open-label, Monocenter, Trial to Investigate the Efficacy and Tolerability of WO533, a Lactic Acid Containing Vaginal Suppository, in a Panel of Post-menopausal Women Suffering From Vulvovaginal Atrophy (VVA)
Actual Study Start Date :
Jan 27, 2020
Actual Primary Completion Date :
Aug 11, 2020
Actual Study Completion Date :
Aug 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: WO533

Formulation containing WO533 for intravaginal application

Drug: WO533
Intravaginal application

Outcome Measures

Primary Outcome Measures

  1. VMI [Day 1 to 43]

    Change of the Vaginal Maturation Index (VMI)

Secondary Outcome Measures

  1. Vaginal pH [Day 1 to 8, day 8 to 43, and day 1 to 43]

    Change of vaginal pH

  2. Subjective vulvovaginal atrophy symptoms [Day 1 to 8, day 8 to 43, and day 1 to 43]

    Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) and as sum score

  3. Global judgment of the tolerability by the Investigator [Day 1 to 43]

    Scoring on a scale from 1 to 4

  4. Global judgment of the tolerability by the patient [Day 1 to 43]

    Scoring on a scale from 1 to 4

  5. Adverse events [Day 1 to 43]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Post-menopausal women with subjective symptomatology of vulvovaginal atrophy

  • Signed written informed consent before participation in the trial

Exclusion Criteria:

  • Known hypersensitivity against any of the ingredients of the investigational product

  • Systemic hormonal replacement therapy, or phytohormonal therapy or use of SERMs within 3 months before and / or during the conduct of the trial

  • Local hormonal therapy (vagina/vulva) within 3 months before the trial

  • If in the opinion of the investigator the patient should not participate in the study for any reason

Contacts and Locations

Locations

Site City State Country Postal Code
1 proDERM Institute for Applied Dermatological Research Schenefeld Germany

Sponsors and Collaborators

  • Dr. August Wolff GmbH & Co. KG Arzneimittel
  • proDERM Institut für Angewandte Dermatologische Forschung GmbH
  • Bremer Pharmacovigilance Service GmbH

Investigators

  • Principal Investigator: Kirstin Deuble-Bente, MD, proDERM Institute for Applied Dermatological Research, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier:
NCT04222647
Other Study ID Numbers:
  • VMP-03/2018
  • 2019-002325-30
First Posted:
Jan 10, 2020
Last Update Posted:
Dec 23, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrophy

Study Results

No Results Posted as of Dec 23, 2021