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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT01577238
First received: April 12, 2012
Last updated: October 27, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Bacterial Vaginosis
Drug: 1% SPL7013 Gel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by Starpharma Pty Ltd:

Primary Outcome Measures:
  • Number of women with Clinical Cure at the Test of Cure visit (TOC) [ Time Frame: Day 21-30 ] [ Designated as safety issue: No ]
    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)


Secondary Outcome Measures:
  • Number of women with Clinical Cure at the End of Treatment visit (EOT) [ Time Frame: Day 9-12 ] [ Designated as safety issue: No ]
  • Number of women with Nugent Cure at the TOC visit [ Time Frame: Day 21-30 ] [ Designated as safety issue: No ]
    Nugent Cure is defined as a score of 0-3

  • Number of women with Nugent Cure at the EOT visit [ Time Frame: Day 9-12 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Screening - TOC ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: March 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VivaGel Drug: 1% SPL7013 Gel
Vaginal gel, daily for 7 days
Other Name: VivaGel
Placebo Comparator: HEC Placebo Drug: Placebo
Vaginal gel, daily for 7 days

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577238

Sponsors and Collaborators
Starpharma Pty Ltd
Investigators
Study Chair: Jeremy Paull, PhD Starpharma Pty Ltd
  More Information

No publications provided

Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov Identifier: NCT01577238     History of Changes
Other Study ID Numbers: SPL7013-015
Study First Received: April 12, 2012
Last Updated: October 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Starpharma Pty Ltd:
SPL7013
VivaGel
bacterial vaginosis
BV

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 15, 2014