Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
| Group | Value (participants) |
|---|---|
| Leuprorelin | 252 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataChina
1 trial · 1 completed · 1 with posted results
A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
NCT024279587 Aug 2015 to 23 Nov 2018
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).
Experimental
Leuprorelin
Participants with body weight greater than or equal to (\>=) 20 kilogram (kg) will receive the recommended dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (\<) 20 kg will receive leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks.
Outcomes the sponsor listed as primary.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame · Day 1 up to Week 100
Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96
Time frame · Week 96
Tanner assessment score was used to document the stage of development of puberty through the assessment of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Regression or no progression was defined as negative change (improvement) or no change in Tanner score at Week 96 compared to baseline.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Leuprorelin | 252 |
| Group | Value (percentage of participants) |
|---|---|
| Leuprorelin | 83.5 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LeuprorelinParticipants with body weight greater than or equal to (\>=) 20 kilogram (kg) received the recommended initial dose of leuprorelin 3.75 milligram (mg), injection, subcutaneously, once every 4 weeks for 96 weeks. Participants with body weight less than (\<) 20 kg received leuprorelin 1.88 mg, injection, subcutaneously, once every 4 weeks for 96 weeks. The dose was adjusted based on participant's condition and investigator's judgment in alignment with the product label in China. | 0 / 307 | 12 / 307 | 189 / 307 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Clinical trial · 2021
Luo et al. 2021Medicinecited by 4
PMID 34941067PMC8702188DOI 10.1097/md.0000000000028158PUB-34941067
Who could join, as posted.
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