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RecruitingNCT04807842Updated Oct 2, 2026

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

An interventional study of vaginal gel in Bacterial Vaginoses, sponsored by BioClin BV. Recruiting at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by BioClin BV · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Bacterial Vaginoses

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03

In context

Vaginosis, Bacterial

220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

This is the only study on the registry with BioClin BV as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Other
    Active product

    Device: vaginal gel

  • Placebo comparator
    Placebo

    Device: vaginal gel

Interventions

  • Devicevaginal gel

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 3 weeks

07

Study locations

1 of 1 sites recruiting
  • Praxis Dr. Peters
    Hamburg, Germany
    • Klaus H Peters, Dr.med · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04807842
Lead sponsor
BioClin BV
Collaborators
Avania
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Jun 11, 2021
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Oct 2, 2026

Study contacts

Diana Zeneli, MD
Contact
diana.pasho@karopharma.com
0031614706949

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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