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Completed

NCT Number: NCT01201057

Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.

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Key information

Conditions

Bacterial Vaginosis 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–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Precision Trials, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
  • Otherwise healthy

Exclusion criteria

  • No active STIs

Treatment and study plan

0.5% SPL7013 Gel

Drug

Vaginal gel

1.0% SPL7013 Gel

Drug

Vaginal gel

3.0% SPL7013 Gel

Drug

Vaginal gel

Placebo gel

Other

Vaginal gel

Primary outcomes

  1. Number of Women With Clinical Cure as a Measure of Efficacy

    Time frame: Day 21-30

    Number of women with clinical cure as determined by absence of BV by the Amsel's criteria

Secondary outcomes

  1. Number of Women With Clinical Cure as a Measure of Efficacy

    Time frame: Day 9-12

    Number of women with clinical cure as determined by absence of BV by the Amsel's criteria

  2. Number of Women With Nugent Cure as a Measure of Efficacy

    Time frame: Day 9-30

    Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.

  3. Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)

    Time frame: Day 9-30

    Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.

  4. Incidence of Genital Adverse Events Potentially Related to Treatment

    Time frame: For the duration of the study (up to Visit Day 21-30)

    Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.

Sponsors and collaborators

Lead sponsor

Starpharma Pty Ltd

Industry

Registry information

Official study title

A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2010
Registry last updated
Jun 6, 2019

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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