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Completed

NCT Number: NCT02237950

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

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.

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Key information

Conditions

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

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Medicine Professional Corporation, Kitchener, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronidazole oral tablets 500mg

Drug

One tablet taken orally twice daily for seven consecutive days

1% SPL7013 Gel

Drug

5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.

Other names: VivaGel, astodimer sodium

Placebo Gel

Drug

5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Primary outcomes

  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 outcomes

  1. Time to 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

    Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)

  2. Recurrence of Patient-reported BV Symptoms

    Time frame: At or by the Week 16 visit

    Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)

  3. Recurrence of Individual Amsel Criteria

    Time frame: At or by the Week 16 visit

    Number of participants with positive 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 Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings

    Time frame: At or by the Week 24 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)

  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. Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score

    Time frame: Baseline to Week 16

    Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.

  8. Adverse Events (AEs)

    Time frame: From Baseline to end of Week 28

    Number of participants with genitourinary AEs considered potentially related to study treatment

Sponsors and collaborators

Lead sponsor

Starpharma Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 12, 2014
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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