AzTrials
AzTrials

Central Precocious PubertyPhase 4NCT02427958

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

A Phase 4 study testing Leuprorelin in people with Central Precocious Puberty, run by Takeda at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 1 year to 9 years
Conditions the study is for
Central Precocious Puberty
What is being tested?
Leuprorelin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
307 participants
Where
9 sitesChina
Study dates
7 Aug 2015to 23 Nov 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.
  • Has a diagnosis of peripheral precocious puberty.
  • 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.
  • 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.
  • If female, the participant is of childbearing potential (eg, not sterilized).
  • 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.
  • If male, the participant intends to donate sperm during the course of this study or for 90 days thereafter.
  • Has participated in another clinical study and/or has received any investigational compound within 30 days prior to Screening.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Study site

    Beijing, Beijing Municipality

  • Study site

    Changchun, Jilin

  • Study site

    Changsha, Hunan

  • Study site

    Hangzhou, Zhejiang

  • Study site

    Nanchang, Jiangxi

  • Study site

    Nanjing, Jiangsu

  • Study site

    Shanghai, Shanghai Municipality

  • Study site

    Wuhan, Hubei

  • Study site

    Wuxi, Jiangsu

Other trials in China

About this study

Official title: An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty

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

Read the detailed description

The drug in this study is called leuprorelin. It is administered as a 1 month subcutaneous depot injection. Leuprorelin is used to treat children who have CPP. This study will look at whether leuprorelin can stop early puberty in pre-pubertal children.

The study will enroll approximately 300 participants. Participants with body weight >=20 kg will receive the recommended dose of leuprorelin 3.75 mg subcutaneous injection every 4 weeks for 96 weeks. Participants with body weight <20 kg will receive recommended dose of 1.88 mg subcutaneous injection every 4 weeks for 96 weeks.

This trial will be conducted in China. The overall time to participate in this study is 104 weeks. Participants will make 11 visits to the clinic, and will be followed-up by the physician on a long-term basis until stable puberty is reached.

Being tested
Leuprorelin
Keywords
Drug Therapy
Medical subject headings
Puberty, Precocious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LeuprorelinDrug

    Also called Enantone

    Suspension for injection.

Study groups in NCT02427958
Study groupRoleWhat they receive
LeuprorelinExperimentalParticipants 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.
Receives: Drug: Leuprorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 up to Week 100

Secondary outcomes (1)

  1. Percentage of Participants With Regression or no Progression in Tanner Staging at 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.

    Measured: Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2015 (estimated)
  2. Study start7 Aug 2015
  3. Primary completion23 Nov 2018
  4. Study completion23 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02427958
Sponsor's protocol ID
Leuprorelin-4001
Other IDs
U1111-1183-0353, CTR20140148
Status last verified
Mar 2022
First submitted
23 Apr 2015
Last updated
16 Mar 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Luo X, Hou L, Zhong Y, You C, Yang Y, Wu X, Li P, Zhou S, Qiu W, Zhang H, Liu Y, Qian Y, Luo F, Cheng R, Hu Y, Gong H, Wang Q, Xu Z, Du H, Lu F, Fu J, Chen X, Wang W, Guo Z. An open label, multicenter clinical trial that investigated the efficacy and safety of leuprorelin treatment of central precocious puberty in Chinese children. Medicine (Baltimore). 2021 Dec 23;100(51):e28158. doi: 10.1097/MD.0000000000028158.

    PubMed 34941067

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Leuprorelin in people with Central Precocious Puberty, run by Takeda at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 up to Week 100). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02427958, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in