NCT01437722

Brief Summary

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

November 20, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

September 20, 2011

Last Update Submit

October 27, 2013

Conditions

Recurrent Bacterial Vaginosis (BV)

Keywords

BVBacterial vaginosisrecurrentSPL7013 GelVivaGel

Outcome Measures

Primary Outcomes (1)

  • Number of women who have experienced a recurrent episode of BV as a measure of efficacy

    Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria

    Day 112 +/- 5

Study Arms (3)

1% SPL7013 Gel

EXPERIMENTAL
Drug: 1% SPL7013 Gel

3% SPL7013 Gel

EXPERIMENTAL
Drug: 3% SPL7013 Gel

placebo gel

PLACEBO COMPARATOR
Drug: placebo gel

Interventions

1% SPL7013 GelDRUG

vaginal gel

1% SPL7013 Gel
3% SPL7013 GelDRUG

vaginal gel

3% SPL7013 Gel
placebo gelDRUG

vaginal gel

placebo gel

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
  • Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
  • Otherwise healthy

You may not qualify if:

  • No active STIs and/or current UTI
  • Previous exposure to SPL7013 Gel
  • A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions \[HSIL\] on cytology or cervical intraepithelial neoplasia \[CIN\] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vaginosis, BacterialRecurrence

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeremy Paull, PhD

    Starpharma Pty Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 21, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2012

Last Updated

November 20, 2013

Record last verified: 2013-10