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Trial record 1 of 41 for:    "familial male-limited precocious puberty" OR "Puberty, Precocious"
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A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty (CPP) Among Chinese Participants

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ClinicalTrials.gov Identifier: NCT02993926
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the long-term safety and efficacy of leuprorelin in the treatment of CPP (of at least 9 months of ENANTONE) in Chinese participants.

Condition or disease Intervention/treatment
Puberty, Precocious Drug: Leuprorelin

Detailed Description:

The drug being evaluated in this study is called leuprorelin. Leuprorelin is used to treat children who have CPP. This study will look at long term safety and efficacy of leuprorelin in the treatment of Chinese participants with CPP.

The study will enroll approximately 300 participants.

All participants who have received leuprorelin 30 mcg/kg to <90 mcg/kg or 90 mcg/kg to 180 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed.

This multi-center trial will be conducted in China. Data will be collected over period of 20 months.


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational, Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious Puberty
Actual Study Start Date : June 24, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018


Group/Cohort Intervention/treatment
Leuprorelin low dose group
Participants who have received leuprorelin 30 microgram per kilogram (mcg/kg) to less than (<) 90 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed.
Drug: Leuprorelin
Leuprorelin suspension for injection
Other Name: Enantone

Leuprorelin high dose group
Participants who have received leuprorelin 90 mcg/kg to 180 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed.
Drug: Leuprorelin
Leuprorelin suspension for injection
Other Name: Enantone




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Index period: from 1 September 1998 to 30 September 2018 (treatment with ENANTONE for 9 months, that is, intiated and received last dose during the index period) ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.

  2. Percentage of Participants who had Regression or no Progression in Tanner Staging [ Time Frame: Index period: from 1 September 1998 to 30 September 2018 (treatment with ENANTONE for 9 months, that is, intiated and received last dose during the index period) ]
    Tanner assessment score is used to document the stage of development of secondary sexual characteristics. Regression or no progression is defined as negative change (improvement) or no change in Tanner score at last observation prior to entry into follow up phase in index period.


Secondary Outcome Measures :
  1. Percentage of Participants With Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Suppression to Pre-pubertal Level [ Time Frame: Index period: from 1 September 1998 to 30 September 2018 (treatment with ENANTONE for 9 months, that is, intiated and received last dose during the index period) ]
    A lab test is conducted to measure LH and FSH levels. Levels are compared to individual pre-puberty levels.

  2. Percentage of Participants With Estradiol or Testosterone Level Suppression to Pre-pubertal Level [ Time Frame: Index period: from 1 September 1998 to 30 September 2018 (treatment with ENANTONE for 9 months, that is, intiated and received last dose during the index period) ]
    A lab test is conducted to measure estradiol and testosterone levels. Levels are compared to individual pre-puberty levels.

  3. Percentage of Participants With a Decrease From Baseline in the Ratio of Bone age to Chronological age (BA/CA ratio) [ Time Frame: Index period: from 1 September 1998 to 30 September 2018 (treatment with ENANTONE for 9 months, that is, intiated and received last dose during the index period) ]
    Bone age (BA) is estimated using an X-ray. Chronological age (CA) at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA is calculated.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with CPP will be observed.
Criteria

Inclusion Criteria:

  1. Has diagnosis of idiopathic CPP.
  2. Has been treated with leuprorelin acetate (Enantone) for at least 9 continuous months of therapy with either a stable dose of high dose (greater than or equal to [>=] 90 mcg/kg up to 180 mcg/kg) or low dose (< 90 mcg/kg down to 30 mcg/kg).
  3. Has initiated and completed treatment during the index period from September 1st 1998 to September 30th 2018.
  4. Have the following information prior to initiation of enantone and at least one record of each of the following parameters at the end of enantone treatment in the medical records: Tanner staging, estradiol or testosterone level, and FSH and LH level. The participant should have at least one record of bone age prior to the intitiation gonadotropin releasing hormone analogs (GnRHa) therapy with enantone to support the diagnosis of CPP. In addition, should have at least one record of bone age during treatment with enantone.

Exclusion Criteria:

  1. Has been treated with leuprorelin acetate or any other GnRHa for conditions other than CPP.
  2. Has used any other GnRHa products for CPP treatment prior to initiation of enantone therapy.
  3. CPP participants with identified etiology, such as brain tumor or cranial irradiation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993926


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
China, Hubei
The Children's Hospital, Zhejiang University School of Medicine Not yet recruiting
Wuhan, Hubei, China, 430030
China, Hunan
Childrens Hospital of Hunan province Not yet recruiting
Changsha, Hunan, China, 410007
China, Jiangsu
Jiangsu Province Hosptial Not yet recruiting
Nanjing, Jiangsu, China, 210036
China, Jiangxi
Children's Hospital of Jiangxi province Not yet recruiting
Nanchang, Jiangxi, China, 330006
China, Shanghai
Children's Hospital of Shanghai Recruiting
Shanghai, Shanghai, China, 200040
China, Zhejiang
The Children's Hospital, Zhejiang University School of Medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310053
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02993926     History of Changes
Other Study ID Numbers: Leuprorelin-5001
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases