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

NCT05211921 | Completed

• 1 other identifier: 21E3559
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relief of vaginal symptoms related to BV at Visit 2

  3 weeks after start of treatment

Study Arms (1)

Multi-Gyn ActiGel Plus

OTHER

vaginal gel

Device: Multi-Gyn ActiGel Plus

Interventions

Multi-Gyn ActiGel Plus DEVICE

vaginal gel

Multi-Gyn ActiGel Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karo Pharma AB: lead

Study Sites (1)

Eurofins Dermascan Poland

Gdansk, Poland

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: December 7, 2021
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)