Treatment of Bacterial Vaginosis with Multi-Gyn ActiGel Plus
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
Run by Karo Pharma AB · NCT04807842 · Data updated 2026-11-12
This study is testing if a new gel called Multi-Gyn ActiGel Plus can help women with bacterial vaginosis feel better compared to a placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Karo Pharma AB Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Hamburg) |
| Status | Recruiting |
| Started | June 11, 2021 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT04807842 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women over 18 years old who have been diagnosed with bacterial vaginosis.
✕Probably not a fit
Patients with current sexually transmitted infections or other specified gynecological conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical investigation aims to evaluate the efficacy of Multi-Gyn ActiGel Plus in treating bacterial vaginosis (BV) compared to a placebo. It is a randomized, double-blind, placebo-controlled study where participants will apply the gel twice daily for seven consecutive days. The study will involve 100 subjects in each treatment arm, with follow-up assessments occurring at three weeks and five weeks post-treatment. The total duration for each participant is estimated to be five weeks, while the overall study will last for 13 months.
Why it matters
Potential benefit: If successful, this treatment could provide an effective non-antibiotic option for women suffering from bacterial vaginosis.
How similar studies have gone: While this approach is not widely tested, similar interventions have shown promise in treating bacterial vaginosis with non-antibiotic therapies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Praxis Dr. Peters
Hamburg, Germany Recruiting
Study contacts
- Study coordinator: Diana Zeneli, MD
- Email: diana.pasho@karopharma.com
- Phone: 0031614706949
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.