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COMPLETED
NCT00322465
PHASE2

NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will compare the 2 currently recommended NGU treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone. Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last 7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2 urethral swabs, and have their urethra checked for discharge indicating infection.

Official title: Phase II Randomized, Placebo-Controlled Double-Blind 4-Arm Trial for the Treatment of Non-Gonococcal Urethritis (NGU): Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

Key Details

Gender

MALE

Age Range

16 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

305

Start Date

2006-11-17

Completion Date

2009-04-20

Last Updated

2026-08-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Doxycycline

100 mg orally, twice daily for 7 days.

OTHER

Placebo

Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline.

DRUG

Tinidazole

2 gm single dose (4 tablets orally at 500 mg each).

DRUG

Azithromycin

1 gram (gm) (2 tablets orally at 500 milligrams (mg) each)

Locations (4)

University of Alabama Hospital - Infectious Diseases

Birmingham, Alabama, United States

Delgado Personal Health Center

New Orleans, Louisiana, United States

Johns Hopkins Hospital - Emergency Department

Baltimore, Maryland, United States

University of North Carolina School of Medicine - Center for Infectious Diseases

Chapel Hill, North Carolina, United States