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

NCT01577238 | Completed Phase 3 Results DMC

• 1 other identifier: SPL7013-015
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Bacterial Vaginosis

Keywords

SPL7013; VivaGel; bacterial vaginosis; BV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Women With Nugent Cure at the EOT Visit

  Day 9-12

• Number of Women With Clinical Cure at the Test of Cure Visit (TOC)

  Day 21-30

• Number of Women With Nugent Cure at the TOC Visit

  Day 21-30

• Adverse Events Potentially Related to Treatment

  Screening/baseline through TOC visit, Day 1-30

Study Arms (2)

VivaGel

EXPERIMENTAL

Drug: 1% SPL7013 Gel

HEC Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

1% SPL7013 Gel DRUG

Vaginal gel, daily for 7 days

Also known as: VivaGel

VivaGel

Placebo DRUG

Vaginal gel, daily for 7 days

HEC Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Starpharma Pty Ltd: lead

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

astodrimer

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr Jeremy Paull
• Organization: Starpharma

jeremy.paull@starpharma.com

Study Officials

• Jeremy Paull, PhD

  Starpharma Pty Ltd

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 13, 2012
• Study Start: March 28, 2012
• Primary Completion: July 20, 2012
• Study Completion: July 20, 2012
• Last Updated: July 17, 2019
• Results First Posted: July 9, 2019

Record last verified: 2019-07