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

Bacterial Vaginosis Clinical Trial

Official title:

A Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211921
• Other study ID #: 21E3559
• Status: Completed
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: May 11, 2022

Study information

• Verified date: August 2022
• Source: Karo Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Device:
• Multi-Gyn ActiGel Plus
vaginal gel

Locations

Country	Name	City	State
Poland	Eurofins Dermascan Poland	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Karo Pharma AB

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).	Primary endpoint is to demonstrate a responder rate significantly higher than 30% in treatment of bacterial vaginosis at 3 weeks after start of treatment using a two tailed binomial test.	3 weeks after start of treatment
Secondary	Relief of vaginal symptoms related to BV at Visit 2	It is based on 0-10 point scale ( 0 is no improvement at all and 10 is the highest improvement)) . It is considered significant if the the score improvement is > 1.	3 weeks after start of treatment