Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population	7 - 14 days after completion of study drug therapy	Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by \> 70% and apyrexia (rectal/tympanic/oral temperature value \< 38.0°C or axillary temperature value \< 37.5°C) and white blood cell count \< 10,500/mm\^3.
Secondary	Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population	7 - 14 days after completion of study drug therapy	For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to "non-success".
Secondary	Clinical Response on Treatment for Per Protocol Population	4 - 7 days after start of therapy	At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by \>30% with improvement in temperature, clinical failure (reduction in severity score of \< or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).
Secondary	Clinical Response on Treatment for Intent To Treat Population	4 - 7 days after start of therapy	Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.
Secondary	Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid	7 - 14 days at TOC visit	The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.
Secondary	Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism	7 - 14 days at TOC visit	Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.
Secondary	Clinical Response at Follow-up Visit on Per Protocol Population	28 - 42 days after completion of study drug therapy	Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.
Secondary	Clinical Response at Follow-up Visit on Intent To Treat Population	28 - 42 days after completion of study drug therapy	All successfully treated subjects and subjects evaluated as"indeterminate" at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes.
Secondary	Bacteriological Response at Follow-up Visit Microbiologically Valid	28 - 42 days after completion of study drug therapy	Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Secondary	Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism	28 - 42 days after completion of study drug therapy	Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Secondary	Number of Subjects Who Received Alternative Medicine	Up to 42 days after end of treatment	As alternative medicine any systemic antibacterial medication was considered.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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