NCT02452931

Brief Summary

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2015

Typical duration for phase_3

Geographic Reach
6 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 31, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 20, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

May 5, 2015

Results QC Date

April 8, 2020

Last Update Submit

May 19, 2020

Conditions

Precocious Puberty, Central

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.

    Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \<4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.

    6 months

Secondary Outcomes (10)

  • Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.

    Week 12, Week 24, Week 36, and Week 48

  • Changes in Height Velocity (Growth Rate)

    Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48

  • Bone Age Ratio to Chronological Age at Time of Measurement

    Week 24 and Week 48

  • Percent Change From Baseline in Height

    Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48

  • Tanner Scores: Boys - Development of External Genitalia

    Baseline, Week 12, Week 24, Week 36, and Week 48

  • +5 more secondary outcomes

Other Outcomes (9)

  • Height

    Screening, Baseline, Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48

  • Bone Age

    Baseline, Week 24, and Week 48

  • Bone Age Progression

    Week 24 and Week 48

  • +6 more other outcomes

Study Arms (1)

Assigned Intervention

EXPERIMENTAL

Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.

Drug: Leuprolide Acetate 45 mg

Interventions

Leuprolide Acetate 45 mgDRUG

Subcutaneous injection

Assigned Intervention

Eligibility Criteria

Age2 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University of California, San Diego

San Diego, California, 92123, United States

Location

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Cincinnati Children's Hospital Medical Center, Endocrine

Cincinnati, Ohio, 45229, United States

Location

University of Oklahoma College of Medicine

Tulsa, Oklahoma, 74135, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Hospital de Ninos

Buenos Aires, C1425EFD, Argentina

Location

University of Calgary, Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

CHU de Quebec-Universite Laval

Québec, G1V 4G2, Canada

Location

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330074, Chile

Location

Instituto de Investigaciones Materno Infantil (IDIMI)

Santiago, Santiago Metropolitan, 8360160, Chile

Location

Hospital Regional de Antofagasta Leonardo Guzman

Antofagasta, Second Region, 1270001, Chile

Location

Hospital Unversitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Location

Instituto de Investigaciones Aplicadas a la Neurociencia, A.C.

Durango, 34000, Mexico

Location

The Liggins Institute, University of Auckland

Auckland, 1023, New Zealand

Location

Related Publications (1)

  • Klein KO, Freire A, Gryngarten MG, Kletter GB, Benson M, Miller BS, Dajani TS, Eugster EA, Mauras N. Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty. J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3660-71. doi: 10.1210/clinem/dgaa479.

    PMID: 32738042DERIVED

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Results Point of Contact

Title
Vice President of Clinical Development
Organization
Tolmar, Inc.
info@tolmar.com
970-212-4500

Study Officials

  • Peggy Schorr

    orphan reach USA, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 25, 2015

Study Start

August 31, 2015

Primary Completion

September 5, 2018

Study Completion

September 5, 2018

Last Updated

June 2, 2020

Results First Posted

May 20, 2020

Record last verified: 2020-05

Locations

US(10)AR(1)ME(2)CA(3)CL(3)NZ(1)