Actively Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Led by BioClin BV · Updated on 2025-09-29
200
Participants Needed
1
Research Sites
285 weeks
Total Duration
On this page
Sponsors
B
BioClin BV
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with bacterial vaginosis using 3 out of 4 Amsel criteria including at least 20% clue cells
- Women of childbearing potential
- Age over 18 years
- Signed written informed consent
- Willingness to follow the study schedule
You will not qualify if you...
- Having current sexually transmitted or other genital infections such as candidosis or aerobic vaginitis
- Presence of Trichomonas or Candida Albicans in vaginal smears
- Current genital cancers
- Chemotherapy in the last 6 months
- Radiotherapy to the genitourinary system in the last 12 months
- Use of antibiotics in the last 14 days
- Use of intravaginal devices currently or in the last 14 days
- Pregnancy or trying to conceive
- Breastfeeding
- Use of other vaginal treatments during the study
- Known allergies to study product ingredients
- Use of medications for vaginal infections or intravaginal medications during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Praxis Dr. Peters
Hamburg, Germany
Actively Recruiting
Research Team
D
Diana Zeneli, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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