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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04807842
Other study ID # MGAP BV 001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 11, 2021
Est. completion date December 1, 2024

Study information

Verified date October 2023
Source Karo Pharma AB
Contact Diana Zeneli, MD
Phone 0031614706949
Email diana.pasho@karopharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control. Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 1, 2024
Est. primary completion date November 1, 2024
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 (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis) - Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel 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 - Use of intravaginal devices during the investigation or 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:
vaginal gel
The placebo gel is a non-buffered gel. The active device is an acidic gel.

Locations

Country Name City State
Germany Praxis Dr. Peters Hamburg

Sponsors (2)

Lead Sponsor Collaborator
BioClin BV Avania

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2). Clinical cure is defined based on the following Amsel criteria:
presence of clue cells <20% of the total epithelial cells on microscopic examination of the saline wet mount
resolution of the abnormal vaginal discharge, and
a negative whiff test
3 weeks
Secondary Microbiological cure rate (based on Nugent score <4) at Visit 2 The secondary objective of the study is to confirm the secondary efficacy of the product. 3 weeks
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