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Completed

NCT Number: NCT01577537

A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

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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

12 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Key eligibility criteria:

  • Post-menarchal females, aged 12 years or more
  • Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
  • Nugent score of at least 4
  • Otherwise healthy, as determined by medical history, physical examination
  • normal Pap smear at or documented within 24 months of screening

Treatment and study plan

1% SPL7013 Gel

Drug

Vaginal gel, daily for 7 days

Other names: VivaGel

Placebo

Drug

Vaginal gel, daily for 7 days

Primary outcomes

  1. Number of Women With Clinical Cure at the End of Treatment Visit (EOT)

    Time frame: Day 9-12

    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

Secondary outcomes

  1. Number of Women With Nugent Cure at the EOT Visit

    Time frame: Day 9-12

    Nugent Cure is defined as a Nugent score of 0-3 (normal)

  2. Number of Women With Clinical Cure at the Test of Cure Visit (TOC)

    Time frame: Day 21-30

    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

  3. Number of Women With Nugent Cure at the TOC Visit

    Time frame: Day 21-30

    Nugent Cure is defined as a Nugent score of 0-3 (normal)

  4. Adverse Events Potentially Related to Treatment

    Time frame: Screening/baseline through TOC visit, Day 1-30

    Number of participants experiencing adverse events considered potentially related to study treatment.

Sponsors and collaborators

Lead sponsor

Starpharma Pty Ltd

Industry

Registry information

Official study title

A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 16, 2012
Registry last updated
Jul 17, 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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