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Trial record 47 of 54 for:    "Vaginitis" | "Metronidazole"

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

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ClinicalTrials.gov Identifier: NCT02237950
Recruitment Status : Completed
First Posted : September 12, 2014
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Starpharma Pty Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Metronidazole oral tablets 500mg Drug: 1% SPL7013 Gel Drug: Placebo gel Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 586 participants
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
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : December 9, 2016
Actual Study Completion Date : February 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)


Secondary Outcome Measures :
  1. Time to Recurrence of BV According to the Primary Efficacy Endpoint Definition [ Time Frame: At or by the Week 16 visit ]
    Time to recurrence of BV (days) according to the primary efficacy endpoint definition

  2. Presence of Patient-reported BV Symptoms [ Time Frame: At or by the Week 16 visit ]
    Patient-reported BV symptoms (vaginal discharge and/or odor)

  3. Recurrence of Individual Amsel Criteria [ Time Frame: At or by the Week 16 visit ]

    Individual Amsel criterion

    - Clue cells representing at least 20% of total epithelial cells


  4. 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 of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.

  5. Recurrence of BV According to the Primary Efficacy Endpoint Definition [ Time Frame: At or by the Week 24 visit ]
    Number of participants with a recurrence of BV according to the primary efficacy endpoint definition

  6. Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10. [ Time Frame: At or by the Week 16 visit ]
    Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.

  7. Adverse Events (AEs) [ Time Frame: From Baseline to end of Week 28 ]
    Number of participants with genitourinary AEs considered potentially related to study treatment



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.


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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current active episode of BV (diagnosis defined as: At least 3 of the 4 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

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): NCT02237950


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Sponsors and Collaborators
Starpharma Pty Ltd
Investigators
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Study Chair: Jeremy Paull, PhD. Starpharma Pty Ltd

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Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov Identifier: NCT02237950     History of Changes
Other Study ID Numbers: SPL7013-017
First Posted: September 12, 2014    Key Record Dates
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019
Last Verified: June 2019

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