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A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

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ClinicalTrials.gov Identifier: NCT03695237
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.

Condition or disease Intervention/treatment Phase
Central Precocious Puberty (CPP) Drug: Leuprolide Acetate (LA) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : May 6, 2020
Estimated Study Completion Date : November 1, 2022


Arm Intervention/treatment
Experimental: Participants receiving Leuprolide Acetate (LA)
Participants with Central Precocious Puberty receiving LA
Drug: Leuprolide Acetate (LA)
It is administered intramuscularly as an injection




Primary Outcome Measures :
  1. Percentage of Participants with suppression of GnRHa-stimulated luteinizing hormone (LH)(<4 milli-international units per milliliter (mlU/mL)) [ Time Frame: At Week 24 ]
    It is measured by peak LH stimulation test


Secondary Outcome Measures :
  1. Percentage of female participants with suppression of basal estradiol to <20 pg/mL [ Time Frame: Up to Week 48 ]
    Female participants with suppression of basal estradiol to < 20 pg/mL are assessed

  2. Percentage of male participants with suppression of testosterone to <30 ng/dL [ Time Frame: Up to Week 48 ]
    Male participants with suppression of testosterone to < 30 ng/dL are assessed

  3. Percentage of participants with maintenance of suppression of GnRHa-stimulated LH (<4 mlU/mL) [ Time Frame: Up to Week 144 ]
    Participants with maintenance of suppression of GnRHa-stimulated LH (<4 mlU/mL) are assessed

  4. Percentage of female participants with maintenance of suppression of basal estradiol to <20 pg/mL [ Time Frame: Up to Week 144 ]
    Female participants with maintenance of suppression of basal estradiol to < 20 pg/mL are assessed

  5. Percentage of male participants with maintenance of suppression of testosterone to <30 ng/dL [ Time Frame: Up to Week 144 ]
    Male participants with maintenance of suppression of testosterone to < 30 ng/dL are assessed

  6. Percentage of participants with suppression of the physical signs of puberty [ Time Frame: Up to Week 144 ]
    Breast development in females, testicular volume or genital development in males will be assessed using modified Tanner staging.

  7. Incremental growth rate [ Time Frame: Up to Week 144 ]
    Incremental growth rate (cm/year) will be assessed.

  8. Ratio of change from baseline in bone age vs chronological age [ Time Frame: Up to Week 144 ]
    Ratio of change from baseline in bone age vs chronological age is assessed

  9. Percentage of Participants with suppression of GnRHa-stimulated luteinizing hormone (LH)(<4 mlU/mL) [ Time Frame: Up to Week 48 ]
    It is measured by peak LH stimulation test



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age).
  • No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.

Exclusion Criteria:

  • NA

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): NCT03695237


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 22 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03695237     History of Changes
Other Study ID Numbers: M16-904
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Central Precocious Puberty (CPP)
Leuprolide Acetate (LA)
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents