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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

Page last updated: August 23, 2015

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