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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Study of Lupron Depot In The Treatment of Central Precocious Puberty

NCTNCT00660010 (opens ClinicalTrials.gov in a new tab)Other idM90-516
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
55 participants (actual)
Sponsor
Abbott · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 1991
Primary completion
Apr 2009
Completion
Apr 2009
First posted
17 Apr 2008 (estimated)
Last update posted
12 Apr 2011 (estimated)
Conditions
Puberty, Precocious

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1995200020052010
  1. Ph 3

    Study of Lupron Depot In The Treatment of Central Precocious Puberty

    NCT00660010

    Jan 1991 to Apr 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.

Interventions

  • Lupron (leuprolide acetate)Drug

Arms1

  • Experimental

    1

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)

    Time frame · Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

    Registry description

    Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).

  2. Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)

    Time frame · Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

    Registry description

    Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).

Secondary outcomes(4)

  1. Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations

    Time frame · Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

    Registry description

    Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years.

  2. Mean Stimulated Estradiol Concentrations in Females

    Time frame · Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

    Registry description

    Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years.

  3. Mean Stimulated Testosterone Concentrations in Males

    Time frame · Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

    Registry description

    Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years.

  4. Mean Ratio of Bone Age to Chronological Age

    Time frame · Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

    Registry description

    Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)

GroupValue (Percentage of subjects)
Leuprolide Acetate 1 Month Depot81.8
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations

GroupValue (mIU/mL)Spread
Leuprolide Acetate 1 Month Depot35.021.32
Secondary outcomeMean· Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Mean Stimulated Estradiol Concentrations in Females

GroupValue (pg/mL)Spread
Leuprolide Acetate 1 Month Depot15.318.73
Secondary outcomeMean· Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Mean Stimulated Testosterone Concentrations in Males

GroupValue (ng/dL)Spread
Leuprolide Acetate 1 Month Depot347.7121.86
Secondary outcomeMean· Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Mean Ratio of Bone Age to Chronological Age

GroupValue (ratio)Spread
Leuprolide Acetate 1 Month Depot1.50.30
Other pre specified outcomeMean· Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males)

Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)

GroupValue (cm)Spread
Leuprolide Acetate 1 Month Depot-0.21.20
Other pre specified outcomeMean· Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)

Mean Time to or Mean Age at Regular Menses in Females After Treatment

GroupValue (years)Spread
Leuprolide Acetate 1 Month Depot1.50.53
Other pre specified outcomeNumber· Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)

Number of Female Subjects Who Reported Regular Menses at Adulthood

GroupValue (Subjects)
Leuprolide Acetate 1 Month Depot16

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Leuprolide Acetate 1 Month DepotLeuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.–7 / 5552 / 55

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLee PA, Neely EK, Fuqua J, Yang D, Larsen LM, Mattia-Goldberg C, Chwalisz K. Efficacy of Leuprolide Acetate 1-Month Depot for Central Precocious Puberty (CPP): Growth Outcomes During a Prospective, Longitudinal Study. Int J Pediatr Endocrinol. 2011;2011(1):7. doi: 10.1186/1687-9856-2011-7. Epub 2011 Jul 12. PMID 21860633

Eligibility

Who could join, as posted.

Sex
All
Age
up to 10 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys. * Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (GnRH) stimulation test (LH \> 10 U/L at baseline). * Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing. * Bone age advanced at least 1 year beyond the chronological age at entry into the study. * The condition may be idiopathic or secondary to another lesion. If secondary, therapy of the primary condition will have been undertaken and stabilized. * No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for premature secretion of gonadotropins. Exclusion Criteria: * Irradiation to the central nervous system. * Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).

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