Status:
COMPLETED
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
Lead Sponsor:
Starpharma Pty Ltd
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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 hist...
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, a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2016
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT02236156
Start Date
October 3 2014
End Date
October 4 2016
Last Update
June 25 2018
Active Locations (30)
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1
Precision Trials, LLC
Phoenix, Arizona, United States, 85032
2
Medical Center for Clinical Research
San Diego, California, United States, 92108
3
Southern Clinical Research Associates
Metairie, Louisiana, United States, 70001
4
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103