Dose-ranging Study of SPL7013 Gel for the Prevention of B... | NCT01437722

Studies
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

NCT01437722

Sponsor

Starpharma Pty Ltd

Status

Completed

Last Update Posted

Nov 20, 2013Estimated

Enrollment

205Actual

Phase

Phase 2

Conditions

Recurrent Bacterial Vaginosis (BV)

Interventions

1% SPL7013 Gel
3% SPL7013 Gel
placebo gel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Not provided

First Submitted Date

Sep 20, 2011

First Submission Date that Met QC Criteria

Sep 20, 2011

First Posted Date

Sep 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Oct 17, 2012

Certification/Extension First Submitted that Passed QC Review

Oct 19, 2012

Certification/Extension First Posted Date

Oct 25, 2012Estimated

Last Update Submitted Date

Oct 27, 2013

Last Update Posted Date

Nov 20, 2013Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1% SPL7013 Gel	Experimental	Drug: 1% SPL7013 Gel
3% SPL7013 Gel	Experimental	Drug: 3% SPL7013 Gel
placebo gel	Placebo Comparator	Drug: placebo gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1% SPL7013 Gel	Drug	vaginal gel	1% SPL7013 Gel
3% SPL7013 Gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremy Paull, PhD	Starpharma Pty Ltd	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial
D012008	Recurrence

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided