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

Last updated: July 8, 2019
Sponsor: Starpharma Pty Ltd
Overall Status: Completed

Phase

3

Condition

Sexually Transmitted Diseases (Stds)

Vaginal Infection

Gynecological Infections

Treatment

N/A

Clinical Study ID

NCT01577537
SPL7013-016
  • Ages > 12
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 251
Study Start date:
April 17, 2012
Estimated Completion Date:
October 05, 2012

Connect with a study center

  • TKL Clincial Research Organisation

    Rochelle Park, New Jersey
    United States

    Site Not Available

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