Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

BioClin Therapeutics

Status: Enrolling

Conditions: Bacterial Vaginoses

Treatments: Device: vaginal gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04807842

MGAP BV 001

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Active product

Other group

Treatment:

Device: vaginal gel

Placebo

Placebo Comparator group

Treatment:

Device: vaginal gel