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Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants

NCTNCT02427958 (opens ClinicalTrials.gov in a new tab)Other idLeuprorelin-4001Other idU1111-1183-0353Other idCTR20140148

Overview

Status
Completed
Phase
Phase 4
Enrollment
307 participants (actual)
Sponsor
Takeda · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
7 Aug 2015
Primary completion
23 Nov 2018
Completion
23 Nov 2018
First posted
28 Apr 2015 (estimated)
Last update posted
16 Mar 2022
Conditions
Central Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 4

    A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants

    NCT02427958

    7 Aug 2015 to 23 Nov 2018

Registry summary

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).

Interventions

  • LeuprorelinDrug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

    Time frame · Day 1 up to Week 100

Secondary outcomes(1)
  1. Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96

    Time frame · Week 96

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 1 up to Week 100

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

GroupValue (participants)
Leuprorelin252
Secondary and other outcome results(1)
Secondary outcomeNumber· Week 96

Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96

GroupValue (percentage of participants)
Leuprorelin83.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 30712 / 307189 / 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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2021

An open label, multicenter clinical trial that investigated the efficacy and safety of leuprorelin treatment of central precocious puberty in Chinese children.

Luo et al. 2021Medicinecited by 4

PMID 34941067PMC8702188DOI 10.1097/md.0000000000028158PUB-34941067

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 1 Year up to 9 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. In the opinion of the investigator, the participant and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements. 2. The participant or the participant's parent(s) or legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Has onset of appearance of secondary sexual characteristic earlier than age 8.0 years in girls or earlier than 9.0 years in boys and the symptom is persistent, and has confirmed diagnosis of CPP. 4. Has basal luteinizing hormone (LH) level greater than (\>) 5.0 international units per liter (IU/L) or peak LH \>3.3 IU/L with LH/follicle-stimulating factor (FSH) \>0.6 in stimulation test. 5. Has evidence of gonadal development evaluated by ultrasonography: ovarian volume \>=1 milliliter (mL) with multiple follicles \>=4 millimeter (mm) in any ovary or uterine enlargement in females or testicular volume \>=4 mL in males. 6. Has advanced bone age (BA) \>=1 year and BA is less than or equal to (\<=) 11.5 years in females or \<=12.5 years in males OR predicted adult height \<150 centimeter (cm) in females or \<160 cm in males OR standard deviation score (SDS) \<-2 standard deviations (SD) OR rapid growth defined as growth of BA /growth of chronologic age \>1. BA is determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards at screening. 7. Has anticipated treatment duration of at least 2 year in investigator's judgment. 8. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 90 days after last dose. 9. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study. 10. The female participant who, at the discretion of the investigator, is deemed to be of child bearing potential must provide negative urine pregnancy text at Day -1 or Day 1 prior to drug administration. Exclusion Criteria: 1. Has received any investigational compound within 30 days prior to Screening. 2. Has received gonadotropin-releasing hormone analog (GnRHa) treatment in a previous clinical study or as a therapeutic agent. 3. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example \[eg\], spouse, parent, child, sibling) or may consent under duress. 4. Has any findings in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial. 5. Has any concomitant medical condition that, in the opinion of the investigator, may expose a participant to an unacceptable level of safety risk or that affects participant compliance. 6. Has any screening abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the participant from entering the study; or the participant has: creatinine \>=1.5 milligram per deciliter (mg/dL), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 times the upper limit of normal (ULN), or total bilirubin \>2.0 mg/dL, with AST/ALT elevated above the limits of normal values. 7. Has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease. 8. Has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound. 9. Has a diagnosis of peripheral precocious puberty. 10. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit. 11. Participant or parent(s), at the discretion of the investigator, is unlikely to comply with the protocol or is unsuitable for any of other reason. 12. If female, the participant is of childbearing potential (eg, not sterilized). 13. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. 14. If male, the participant intends to donate sperm during the course of this study or for 90 days thereafter. 15. Has participated in another clinical study and/or has received any investigational compound within 30 days prior to Screening.

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