Bacterial VaginosesNCT04807842

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

A study testing vaginal gel in people with Bacterial Vaginoses, run by BioClin BV at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Bacterial Vaginoses
What is being tested?: vaginal gel
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteGermany
Study dates: 11 Jun 2021to 1 Dec 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Diana Zeneli, MD contact

0031614706949

diana.pasho@karopharma.com

Germany1 site, 1 recruiting

Praxis Dr. Peters
Hamburg
Klaus H Peters, Dr.med
Recruiting

Other trials in Germany

About this study

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

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.

Conditions: Bacterial Vaginoses
Being tested: vaginal gel
Medical subject headings: Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vaginal gelDevice
The placebo gel is a non-buffered gel. The active device is an acidic gel.

Study groups in NCT04807842
Study group	Role	What they receive
Active product	Other	Not described Receives: Device: vaginal gel
Placebo	Placebo comparator	Not described Receives: Device: vaginal gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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:
1. presence of clue cells <20% of the total epithelial cells on microscopic examination of the saline wet mount
2. resolution of the abnormal vaginal discharge, and
3. a negative whiff test
Measured: 3 weeks

Secondary outcomes (1)

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.
Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 20211 Dec 2026

First posted19 Mar 2021
Study start11 Jun 2021
Primary completion1 Dec 2026 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bacterial VaginosesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: double blinded, randomized placebo controlled.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04807842
Sponsor's protocol ID: MGAP BV 001
Status last verified: Sep 2026
First submitted: 18 Mar 2021
Last updated: 2 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No