Status:
RECRUITING
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Lead Sponsor:
BioClin BV
Collaborating Sponsors:
Avania
Conditions:
Bacterial Vaginoses
Eligibility:
FEMALE
18+ years
Phase:
NA
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 cont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04807842
Start Date
June 11 2021
End Date
December 1 2026
Last Update
September 29 2025
Active Locations (1)
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1
Praxis Dr. Peters
Hamburg, Germany