Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Bacterial Vaginoses
In brief
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.
Key facts
- Study ID
- NCT04807842
- Run by
- BioClin BV
- People needed
- 200
- Starts
- 2021-06-11
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-09-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Praxis Dr. Peters — Hamburg, Germany (enrolling)
Full record on ClinicalTrials.gov
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