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OpenTrials
Completed

NCT Number: NCT04222647

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

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.

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Key information

Conditions

Vulvovaginal Atrophy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

proDERM Institute for Applied Dermatological Research

Schenefeld, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

WO533

Drug

Intravaginal application

Primary outcomes

  1. VMI

    Time frame: Day 1 to 43

    Change of the Vaginal Maturation Index (VMI)

Secondary outcomes

  1. Vaginal pH

    Time frame: Day 1 to 8, day 8 to 43, and day 1 to 43

    Change of vaginal pH

  2. Subjective vulvovaginal atrophy symptoms

    Time frame: 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

    Time frame: Day 1 to 43

    Scoring on a scale from 1 to 4

  4. Global judgment of the tolerability by the patient

    Time frame: Day 1 to 43

    Scoring on a scale from 1 to 4

  5. Adverse events

    Time frame: Day 1 to 43

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Collaborators

  • Bremer Pharmacovigilance Service GmbH
  • proDERM Institut für Angewandte Dermatologische Forschung GmbH

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2020
Registry last updated
Dec 23, 2021

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.

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