Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
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| ClinicalTrials.gov Identifier: NCT02452931 |
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Recruitment Status :
Completed
First Posted : May 25, 2015
Last Update Posted : July 3, 2019
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Sponsor:
Tolmar Inc.
Information provided by (Responsible Party):
Tolmar Inc.
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Brief Summary:
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Precocious Puberty, Central | Drug: Leuprolide Acetate 45 mg | Phase 3 |
Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty |
| Actual Study Start Date : | August 31, 2015 |
| Actual Primary Completion Date : | September 5, 2018 |
| Actual Study Completion Date : | September 5, 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Central precocious puberty
Familial male-limited precocious puberty
MedlinePlus related topics:
Puberty
Drug Information available for:
Leuprolide acetate
| Arm | Intervention/treatment |
|---|---|
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Experimental: Assigned Intervention
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
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Drug: Leuprolide Acetate 45 mg
Subcutaneous injection |
Primary Outcome Measures :
- Percentage of Participants with Suppression of Peak-Stimulated Luteinizing Hormone at 6 months. [ Time Frame: 6 months ]Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4mIU/mL. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.
Secondary Outcome Measures :
- Percentage of subjects with suppression of luteinizing hormone measured by blood levels. [ Time Frame: Up to 12 months ]
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| Ages Eligible for Study: | 2 Years to 9 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)
- Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
- Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation
- Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males
- Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
Exclusion Criteria:
- Gonadotropin-independent (peripheral) precocious puberty
- Prior or current GnRH treatment for CPP
- Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
- Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age)
- Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
- Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study
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): NCT02452931
Locations
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Joe DiMaggio Children's Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Nemours Children's Hospital | |
| Orlando, Florida, United States, 32827 | |
| United States, Indiana | |
| Riley Hospital for Children at Indiana University Health | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55414 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center, Endocrine | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Oklahoma | |
| University of Oklahoma College of Medicine | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Washington | |
| Seattle Children's | |
| Seattle, Washington, United States, 98105 | |
| MultiCare Institute for Research and Innovation | |
| Tacoma, Washington, United States, 98405 | |
| Argentina | |
| Hospital de Ninos | |
| Buenos Aires, Argentina, C1425EFD | |
| Canada, Alberta | |
| University of Calgary, Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Canada, Quebec | |
| McGill University Health Centre | |
| Montreal, Quebec, Canada, H4A 3J1 | |
| Canada | |
| CHU de Quebec-Universite Laval | |
| Quebec, Canada, G1V 4G2 | |
| Chile | |
| Pontificia Universidad Catolica de Chile | |
| Santiago, Metropolitana, Chile, 8330074 | |
| Instituto de Investigaciones Materno Infantil (IDIMI) | |
| Santiago, Metropolitana, Chile, 8360160 | |
| Hospital Regional de Antofagasta Leonardo Guzman | |
| Antofagasta, Second Region, Chile, 1270001 | |
| Mexico | |
| Hospital Unversitario "Dr. Jose Eleuterio Gonzalez" | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Instituto de Investigaciones Aplicadas a la Neurociencia, A.C. | |
| Durango, Mexico, 34000 | |
| New Zealand | |
| The Liggins Institute, University of Auckland | |
| Auckland, New Zealand, 1023 | |
Sponsors and Collaborators
Tolmar Inc.
Investigators
| Study Director: | Peggy Schorr | orphan reach USA, LLC |
| Responsible Party: | Tolmar Inc. |
| ClinicalTrials.gov Identifier: | NCT02452931 History of Changes |
| Obsolete Identifiers: | NCT02811471 |
| Other Study ID Numbers: |
TOL2581A |
| First Posted: | May 25, 2015 Key Record Dates |
| Last Update Posted: | July 3, 2019 |
| Last Verified: | July 2019 |
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 |