A Phase 3 interventional study of ceftriaxone 500-mg and ceftriaxone 1000-mg in Gonorrhea Infection, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by National Taiwan University Hospital · Phase 3, Interventional, and Treatment
This is a study to compare the treatment effect of different doses of ceftriaxone for gonorrhea.
This is a noninferiority randomized controlled trial to compare the treatment effect of 500-mg to 1000-mg of ceftriaxone for uncomplicated gonorrhea infection in men.
167 studies on the registry are indexed under Gonorrhea; 31 are open to participants now.
This study's planned enrollment of 400 is close to the median of 400 across 125 interventional studies indexed under Gonorrhea.
Browse Gonorrhea studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution
Drug: ceftriaxone 500-mg
single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution
Drug: ceftriaxone 1000-mg
single-dose ceftriaxone 500-mg intramuscular injection, dissolved in 2 mL of 1% lidocaine hydrochloride solution
single-dose ceftriaxone 1000-mg intramuscular injection, dissolved in 3.5 mL of 1% lidocaine hydrochloride solution
Treatment response of UGI
The proportion of participants with successful treatment of UGI, defined as a NAAT-negative and, if applicable, a culture-negative result of the primary anatomic sites of infection 7-14 days after treatment; a culture-negative result is required only if N. gonorrhoeae culture was positive at the screening visit.
Time frame: From enrollment to 14 days after treatment
Symptom duration
Symptom duration, including dysuria, genital discharge, sore throat, anorectal pain, rectal bleeding, and rectal discharge, in the subgroup of patients who have baseline symptoms attributable to UGIs.
Time frame: From enrollment to 14 days after treatment
Treatment-related adverse events
Treatment-related adverse events until 14 days after treatment.
Time frame: From enrollment to 14 days after treatment
MIC of ceftriaxone of isolates
MIC of ceftriaxone of isolates at screening and test-of-cure (TOC) visits.
Time frame: From enrollment to 14 days after treatment
NG-MAST
NG-MAST at screening and TOC visits.
Time frame: From enrollment to 14 days after treatment
Gene mutations associated with drug resistance for extended-spectrum cephalosporins
Gene mutations associated with drug resistance for extended-spectrum cephalosporins at screening and TOC visits.
Time frame: From enrollment to 14 days after treatment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Taiwan University Hospital →