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NCT Number: NCT04807842

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.

Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Praxis Dr. Peters

Hamburg, Germany

Location status: Recruiting

Location contact

Klaus H Peters, Dr.med

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
  • Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel 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
  • Use of intravaginal devices during the investigation or 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

Treatment and study plan

vaginal gel

Device

The placebo gel is a non-buffered gel. The active device is an acidic gel.

Primary outcomes

  1. Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).

    Time frame: 3 weeks

    Clinical cure is defined based on the following Amsel criteria:

    • presence of clue cells <20% of the total epithelial cells on microscopic examination of the saline wet mount
    • resolution of the abnormal vaginal discharge, and
    • a negative whiff test

Secondary outcomes

  1. Microbiological cure rate (based on Nugent score <4) at Visit 2

    Time frame: 3 weeks

    The secondary objective of the study is to confirm the secondary efficacy of the product.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Zeneli, MD

CONTACT

[email protected]

0031614706949

Sponsors and collaborators

Lead sponsor

BioClin BV

Industry

Collaborators

  • Avania

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2021
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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