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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577238
• Other study ID #: SPL7013-015
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2012
• Est. completion date: July 20, 2012

Study information

• Verified date: July 2019
• Source: Starpharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 20, 2012
• Est. primary completion date: July 20, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• 1% SPL7013 Gel
Vaginal gel, daily for 7 days
• Placebo
Vaginal gel, daily for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Starpharma Pty Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Women With Clinical Cure at the End of Treatment Visit (EOT)	Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)	Day 9-12
Secondary	Number of Women With Nugent Cure at the EOT Visit	Nugent Cure is defined as a Nugent score of 0-3 (normal)	Day 9-12
Secondary	Number of Women With Clinical Cure at the Test of Cure Visit (TOC)	Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)	Day 21-30
Secondary	Number of Women With Nugent Cure at the TOC Visit	Nugent Cure is defined as a Nugent score of 0-3 (normal)	Day 21-30
Secondary	Adverse Events Potentially Related to Treatment	Number of participants with adverse events considered potentially related to study treatment	Screening/baseline through TOC visit, Day 1-30