AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

RecruitingNAAges 18 Years - anyFemaleBioClin BV
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • vaginal gel
๐Ÿ“

Where

1 site
Praxis Dr. Peters
Hamburg, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy