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Completed

NCT Number: NCT00667446

Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).

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Key information

Conditions

Precocious Central Precocious Puberty (CPP) Depot Formulation Endocrine System Diseases GnRH Analog Gonadal Disorders Gonadotrophin-releasing Hormone (GnRH) Gonadotrophin-releasing Hormone Agonist (GnRHa) Leuprolide Acetate Lupron Luteinizing Hormone (LH) Pediatrics Central Precocious Puberty Puberty, Precocious Suppression of LH Tanner Staging

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 23182, Bayamón, Puerto Rico

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About this study

This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone <4 mIU/mL at the Month 6 study visit of the lead-in study.
  • Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in study.
  • Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry.
  • In general good health with no uncontrolled, clinically significant disease which would interfere with bone maturation or mask the objectives of this protocol as assessed by the investigator.

Exclusion criteria

  • Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
  • Bone age ≥14 years for girls and ≥15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results).
  • Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition.
  • Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
  • Current therapy with medroxyprogesterone acetate.
  • Current therapy with growth hormone.
  • Current therapy with insulin-like growth factor-1 (IGF-1).
  • Current use of an estrogen preparation.
  • Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance.
  • Subject has a positive pregnancy test.

Treatment and study plan

Leuprolide Acetate 3 Month Depot

Drug

Other names: ABT-818, Lupron, Leuprorelin acetate

Primary outcomes

  1. Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone

    Time frame: Day 1, Months 6, 12, 24, and 36

    Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.

Secondary outcomes

  1. Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)

    Time frame: Day 1, Months 3, 6, 9, 12, and 24

    The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.

    The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36.

  2. Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)

    Time frame: Months 6, 9, 12, 24, 30, and 36

    The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.

    The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36.

  3. Percentage of Male Participants With Suppression of Basal Testosterone

    Time frame: Day 1, Months 3, 6, 9, 12, 24, 30, and 36

    The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36.

  4. Mean Peak-stimulated Luteinizing Hormone Concentration by Visit

    Time frame: Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36

    Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.

  5. Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)

    Time frame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36

    The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.

  6. Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)

    Time frame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36

    The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.

  7. Change From Baseline in Growth Rate

    Time frame: Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36

    Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.

  8. Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age

    Time frame: Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36

    Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula:

    (BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline).

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Apr 28, 2008
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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