Safety and Tolerability of Metronidazole Gel 1.3%
Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaginosis, Bacterial
Intervention: Metronidazole Gel (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Watson Pharmaceuticals Official(s) and/or principal investigator(s): Branka Palic, Study Director, Affiliation: Watson Pharmaceuticals, A Subsidiary of Actavis, plc
Overall contact: Allan Spera, Phone: 866-369-5227, Ext: 58399, Email: Allan.Spera@Actavis.com
Summary
Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal
Gel in females 12 to <18 years for the treatment of bacterial vaginosis.
Clinical Details
Official title: A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Metronidazole Vaginal Gel 1.3% in Adolescent Female Subjects With Bacterial Vaginosis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of subjects with treatment-emergent adverse events (AEs), serious AEs, treatment-related AEs and AEs leading to study discontinuation after Metronidazole Vaginal Gel is administered in post-menarcheal, adolescent females with bacterial vaginosis.
Secondary outcome: Number of subjects reporting presence of daily vaginal discharge and/or odor following single dose administration of Metronidazole Vaginal Gel 1.3%ssessment of the presence of vaginal discharge and odor following single dose administration.
Detailed description:
A multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal
Gel 1. 3% when administered as a single dose in adolescent females (aged 12 to <18 years) for
the treatment of bacterial vaginosis.
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Provide written assent and parent/legal guardian informed consent and authorization
to disclose protected health information.
- Post-menarcheal, adolescent female, 12 to <18 years of age at time of
Screening/Baseline Visit (Day 1).
- In good general health at Screening visit with no known medical conditions that, in
the Investigator's opinion, may interfere with study participation.
- Has negative urine pregnancy test result prior to study treatment initiation.
- Has clinical diagnosis of bacterial vaginosis.
- Agree to abstain from sexual intravaginal intercourse for study duration.
- Willing to avoid alcohol ingestion for 24 hours after administration of test article.
- Agree to refrain from use of intravaginal products for duration of study (e. g.
lubricated condoms, tampons, diaphgrams, spermicides, feminine deodorant sprays,
douches). Intravaginal Uterine Device (IUD) use is acceptable as long as it has been
in place for 30 days prior to study enrollment.
- Willing and able to participate in study, make required visits to the study center,
and comply with all study requirements including concomitant medication and other
treatment restrictions.
Exclusion Criteria:
- Pregnant, lactating, or planning to become pregnant during study period.
- Currently menstruating or anticipate onset of menses during first 9 days of the
study.
- Experience a clinically important medical event with 90 days of Screening/Baseline
Visit (Day 1).
- Evidence of other infectious causes of vulvovaginal infection or condition that in
the Investigator's opinion would confound the interpretation of the study results.
- Severe symptoms of dysuria and/or pruritus, burning or irritation in vulvovaginal
area.
- Received systemic or intravaginal antifungal, antibacterial or antiparasitic drugs
within 14 days of Screening/Baseline visit (Day 1). Antiviral therapies
(non-intravaginal) are acceptable.
- Has taken disulfiram or systemic corticosteroids (oral or injected) within 14 days of
Screening/Baseline Visit (Day 1).
- Had sexual intravaginal intercourse within 24 hours of Screening/Baseline (Day 1).
- Demonstrated previous hypersensitivity to metronidazole, either orally or topically
administered, or any form of parabens or benzyl alcohol.
- Known primary or secondary immunodeficiency condition/syndrome.
- Being treated or planning to be treated during the study period for cervical
intraepithelial neoplasia (CIN) or cervical carcinoma.
- Using anticoagulation therapy with Coumadin (warfarin).
- Previously treated with test article under this protocol.
- Participate in an experimental drug/device trial within the last 30 days before
Screening/Baseline Visit (Day 1).
- Is judged by the Investigator to be unsuitable for any reason.
Locations and Contacts
Allan Spera, Phone: 866-369-5227, Ext: 58399, Email: Allan.Spera@Actavis.com
Actavis Research Site #303, Birmingham, Alabama 35233, United States; Recruiting
Actavis Research Site #308, New Haven, Connecticut 06511, United States; Withdrawn
Actavis Research Site #310, Miami, Florida 33142, United States; Recruiting
Actavis Research Site #301, North Miami Beach, Florida 33162, United States; Recruiting
Actavis Research Site #311, Lincoln, Nebraska, United States; Not yet recruiting
Actavis Research Site #312, Lincoln, Nebraska 68510, United States; Recruiting
Actavis Research Site #302, Las Vegas, Nevada 89128, United States; Recruiting
Actavis Research Site #304, Las Vegas, Nevada 89106, United States; Recruiting
Actavis Research Site #307, Houston, Texas 77023, United States; Recruiting
Actavis Research Site #305, Norfolk, Virginia 23507-1627, United States; Recruiting
Additional Information
Starting date: March 2015
Last updated: July 28, 2015
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