Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

NCT ID: NCT05211921

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2022-05-11

Brief Summary

Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multi-Gyn ActiGel Plus

vaginal gel

Group Type: OTHER

Multi-Gyn ActiGel Plus

Intervention Type: DEVICE

vaginal gel

Interventions

Multi-Gyn ActiGel Plus

vaginal 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
• Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amsel 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
• 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

Karo Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofins Dermascan Poland

Gdansk, , Poland

Countries

Poland

Other Identifiers

21E3559

Identifier Type: -

Identifier Source: org_study_id