NCT04222647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2020

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

October 9, 2019

Last Update Submit

December 22, 2021

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (1)

  • VMI

    Change of the Vaginal Maturation Index (VMI)

    Day 1 to 43

Secondary Outcomes (5)

  • Vaginal pH

    Day 1 to 8, day 8 to 43, and day 1 to 43

  • Subjective vulvovaginal atrophy symptoms

    Day 1 to 8, day 8 to 43, and day 1 to 43

  • Global judgment of the tolerability by the Investigator

    Day 1 to 43

  • Global judgment of the tolerability by the patient

    Day 1 to 43

  • Adverse events

    Day 1 to 43

Study Arms (1)

WO533

EXPERIMENTAL

Formulation containing WO533 for intravaginal application

Drug: WO533

Interventions

WO533DRUG

Intravaginal application

WO533

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women with subjective symptomatology of vulvovaginal atrophy
  • Signed written informed consent before participation in the trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

proDERM Institute for Applied Dermatological Research

Schenefeld, Germany

Location

Related Publications (1)

  • 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: 36787527DERIVED

Study Officials

  • Kirstin Deuble-Bente, MD

    proDERM Institute for Applied Dermatological Research, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2019

First Posted

January 10, 2020

Study Start

January 27, 2020

Primary Completion

August 11, 2020

Study Completion

August 11, 2020

Last Updated

December 23, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)