Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
ConditionBacterial Vaginoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBioClin BV
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- vaginal gel
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
BioClin BV
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov