Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

NCT ID: NCT04807842

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2026-12-01

Brief Summary

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.

Conditions

Bacterial Vaginoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active product

Group Type: OTHER

vaginal gel

Intervention Type: DEVICE

The placebo gel is a non-buffered gel. The active device is an acidic gel.

Placebo

Group Type: PLACEBO_COMPARATOR

vaginal gel

Intervention Type: DEVICE

The placebo gel is a non-buffered gel. The active device is an acidic gel.

Interventions

vaginal gel

The placebo gel is a non-buffered gel. The active device is an acidic gel.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Avania

INDUSTRY

Sponsor Role: collaborator

BioClin BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Praxis Dr. Peters

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Diana Zeneli, MD

Role: CONTACT

diana.pasho@karopharma.com

0031614706949

Facility Contacts

Klaus H Peters, Dr.med

Role: primary

Other Identifiers

MGAP BV 001

Identifier Type: -

Identifier Source: org_study_id