Treatment of Bacterial Vaginosis with Multi-Gyn ActiGel Plus
A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karo Pharma AB Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT04807842 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old who have been diagnosed with bacterial vaginosis.
Not a fit: Patients with current sexually transmitted infections or other specified gynecological conditions may not benefit from this study.
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 performed: While this approach is not widely tested, similar interventions have shown promise in treating bacterial vaginosis with non-antibiotic therapies.
Eligibility criteria
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 this trial is running
Hamburg
- Praxis Dr. Peters — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Diana Zeneli, MD
- Email: diana.pasho@karopharma.com
- Phone: 0031614706949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.