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

Karo Pharma

Status

Completed

Conditions

Bacterial Vaginosis

Treatments

Device: Multi-Gyn ActiGel Plus

Study type

Interventional

Funder types

Industry

Identifiers

NCT05211921

21E3559

Details and patient eligibility

About

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.

Enrollment

50 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
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