Status:
COMPLETED
Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Lead Sponsor:
Karo Pharma AB
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18+ years
Phase:
NA
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 A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05211921
Start Date
December 7 2021
End Date
May 11 2022
Last Update
August 18 2022
Active Locations (1)
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1
Eurofins Dermascan Poland
Gdansk, Poland