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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014