CompletedPhase 4

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

China307 participantsStarted 2015-08-07

Plain-language summary

The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).

Who can participate

Age range1 Year – 9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. In the opinion of the investigator, the participant and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
✓. 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.
✓. 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.
✓. 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.
✓. 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.
✓. 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.
✓. Has anticipated treatment duration of at least 2 year in investigator's judgment.
✓. 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.

Exclusion criteria

✕. Has received any investigational compound within 30 days prior to Screening.
✕. Has received gonadotropin-releasing hormone analog (GnRHa) treatment in a previous clinical study or as a therapeutic agent.
✕. 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.
✕. 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.
✕. 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.
✕. 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.
✕. Has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
✕. Has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.

What they're measuring

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

Timeframe: Day 1 up to Week 100

Trial details

NCT IDNCT02427958

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-23

Results submitted2019-05-21

View on ClinicalTrials.gov More Central Precocious Puberty trials