Bacterial Vaginoses Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Praxis Dr. Peters | Hamburg |
Lead Sponsor | Collaborator |
---|---|
BioClin BV | Avania |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2). | Clinical cure is defined based on the following Amsel criteria:
presence of clue cells <20% of the total epithelial cells on microscopic examination of the saline wet mount resolution of the abnormal vaginal discharge, and a negative whiff test |
3 weeks | |
Secondary | Microbiological cure rate (based on Nugent score <4) at Visit 2 | The secondary objective of the study is to confirm the secondary efficacy of the product. | 3 weeks |
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