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Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

B

BioClin Therapeutics

Status

Enrolling

Conditions

Bacterial Vaginoses

Treatments

Device: vaginal gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT04807842
MGAP BV 001

Details and patient eligibility

About

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.

Enrollment

200 estimated 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 (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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups, including a placebo group

Active product
Other group
Treatment:
Device: vaginal gel
Placebo
Placebo Comparator group
Treatment:
Device: vaginal gel

Trial contacts and locations

1

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Central trial contact

Diana Zeneli, MD

Data sourced from clinicaltrials.gov

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