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Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02236156
First Posted: September 10, 2014
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Starpharma Pty Ltd
  Purpose
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.

Condition Intervention Phase
Bacterial Vaginosis Drug: Metronidazole oral tablets 500mg Drug: 1% SPL7013 Gel Drug: Placebo gel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis.

Resource links provided by NLM:


Further study details as provided by Starpharma Pty Ltd:

Primary Outcome Measures:
  • Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings [ Time Frame: At or by the Week 16 visit ]
    Number of participants with a recurrence


Secondary Outcome Measures:
  • Time to recurrence of BV according to the primary efficacy endpoint definition [ Time Frame: At or by the Week 28 visit ]
    Time (days)

  • Presence of patient-reported BV symptoms [ Time Frame: At or by the Week 16 visit ]
    Number of participants with symptoms

  • Recurrence of individual Amsel criteria [ Time Frame: At or by the Week 16 visit ]

    Individual Amsel criteria are:

    i) Presence of homogenous vaginal discharge characteristic of BV

    ii) Positive whiff test

    iii) Clue cells representing at least 20% of total epithelial cells

    iv) vaginal fluid pH greater than 4.5


  • Recurrence of BV as determined by presence of a Nugent score of 7-10 [ Time Frame: At or by the Week 16 visit ]
    Number of participants with a recurrence

  • Recurrence of BV according to the primary efficacy endpoint definition [ Time Frame: At or by the Week 20, 24 and 28 visits ]
    Number of participants with a recurrence

  • Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4 [ Time Frame: At or by the Week 16 visit ]
    Number of participants with a recurrence

  • Adverse events (AEs) [ Time Frame: Study duration ]
    Number of participants

  • Responses to Quality of Life (QoL) Questionnaires [ Time Frame: Screening to Week 16 ]

Enrollment: 637
Actual Study Start Date: September 2014
Study Completion Date: March 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1% SPL7013 Gel
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Drug: Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
Drug: 1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
Other Names:
  • VivaGel
  • astodimer sodium
Placebo Comparator: Placebo Gel
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Drug: Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
Drug: Placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Detailed Description:

Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.

The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.

Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.

Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)
  • History of recurrent BV (at least 3 episodes in previous year including current episode)
  • Using an effective method of contraception

Exclusion Criteria:

  • Test positive for a sexually transmitted infection
  • Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
  • Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236156


Locations
United States, Arizona
Precision Trials, LLC
Phoenix, Arizona, United States, 85032
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
United States, Louisiana
Southern Clinical Research Associates
Metairie, Louisiana, United States, 70001
United States, North Carolina
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
Bulgaria
Sites Various
Pleven, Bulgaria
Sites Various
Plovidiv, Bulgaria
Sites Various
Sofia, Bulgaria
Sites Various
Stara Zagora, Bulgaria
Czechia
Sites Various
Brno, Czechia
Sites Various
Ceske Budejovice, Czechia
Sites Various
Olomouc, Czechia
Sites Various
Pisek, Czechia
Sites Various
Praha 2, Czechia
Sites Various
Vsetin, Czechia
Hungary
Sites Various
Baja, Hungary
Sites Various
Balatonfured, Hungary
Sites Various
Budapest, Hungary
Sites Various
Debrecen, Hungary
Sites Various
Gyomro, Hungary
Sites Various
Komarom, Hungary
Sites Various
Letavertes, Hungary
Sites Various
Zalaegerszeg, Hungary
Ukraine
Sites Various
Ivano-Frankivsk, Ukraine
Sites Various
Kyiv, Ukraine
Sites Various
Zaporizhzhia, Ukraine
United Kingdom
Sites Various
Birmingham, United Kingdom
Sites Various
Coventry, United Kingdom
Sites Various
Leeds, United Kingdom
Sites Various
London, United Kingdom
Sites Various
Plymouth, United Kingdom
Sponsors and Collaborators
Starpharma Pty Ltd
Investigators
Study Chair: Jeremy Paull, PhD. Starpharma Pty Ltd
  More Information

Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov Identifier: NCT02236156     History of Changes
Other Study ID Numbers: SPL7013-018
First Submitted: September 5, 2014
First Posted: September 10, 2014
Last Update Posted: December 7, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Recurrence
Vaginal Diseases
Vaginosis, Bacterial
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents