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Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Primary Purpose

Bacterial Vaginoses

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
vaginal gel
Sponsored by
BioClin BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Praxis Dr. PetersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

Active product

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 18, 2021
Last Updated
October 3, 2023
Sponsor
BioClin BV
Collaborators
Avania
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1. Study Identification

Unique Protocol Identification Number
NCT04807842
Brief Title
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Official Title
A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioClin BV
Collaborators
Avania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blinded, randomized placebo controlled.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active product
Arm Type
Other
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
vaginal gel
Intervention Description
The placebo gel is a non-buffered gel. The active device is an acidic gel.
Primary Outcome Measure Information:
Title
Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).
Description
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
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Microbiological cure rate (based on Nugent score <4) at Visit 2
Description
The secondary objective of the study is to confirm the secondary efficacy of the product.
Time Frame
3 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Zeneli, MD
Phone
0031614706949
Email
diana.pasho@karopharma.com
Facility Information:
Facility Name
Praxis Dr. Peters
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus H Peters, Dr.med

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

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