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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05211921
Other study ID # 21E3559
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2021
Est. completion date May 11, 2022

Study information

Verified date August 2022
Source Karo Pharma AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 11, 2022
Est. primary completion date May 11, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (>20%) - Women of childbearing potential - Aged >18 years - Signed written informed consent form - Willing to comply to the follow-up schedule Exclusion Criteria: - Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis - Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amsel criteria (clue cells detection) - Current genital malignancies - Chemotherapy for any reason in last 6 months - Radiotherapy in the genitourinary system in the last 12 months - Use of antibiotics for any reason in the last 14 days - Pregnancy or currently attempting to conceive - Lactation - Use of other treatment for vaginal conditions during the course of the clinical investigation - Known allergies to ingredients of the product - Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation

Study Design


Intervention

Device:
Multi-Gyn ActiGel Plus
vaginal gel

Locations

Country Name City State
Poland Eurofins Dermascan Poland Gdansk

Sponsors (1)

Lead Sponsor Collaborator
Karo Pharma AB

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2). Primary endpoint is to demonstrate a responder rate significantly higher than 30% in treatment of bacterial vaginosis at 3 weeks after start of treatment using a two tailed binomial test. 3 weeks after start of treatment
Secondary Relief of vaginal symptoms related to BV at Visit 2 It is based on 0-10 point scale ( 0 is no improvement at all and 10 is the highest improvement)) . It is considered significant if the the score improvement is > 1. 3 weeks after start of treatment
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