Clinical Trial: Study of Lupron Depot In The Treatment of Central Precocious Puberty

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of Lupron Depot In The Treatment of Central Precocious Puberty

Brief Summary: 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.

Detailed Summary:

This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old.

At the treatment visits, efficacy assessments are Tanner staging (suppression of breast development in females and genital development in males), gonadotropins (LH and FSH), sex steroids (estradiol in females and testosterone in males), ratio of bone age to chronological age, adult height compared to a standard population and predicted mature height, and age and time to regular menses in females. This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.


Sponsor: Abbott

Current Primary Outcome:

  • 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 ]
    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).
  • 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 ]
    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).


Original Primary Outcome: The clinical sexual characteristics evaluated using Tanner staging (pubic hair and genital development in males, pubic hair and breast development in females). [ Time Frame: Weeks 4, 8, 12, 24, 36, 48, then every 6 months until end of treatment, and end of treatment day. ]

Current Secondary Outcome:

  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.


Original Secondary Outcome:

  • Hormone laboratory test results (LH suppression). [ Time Frame: Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until end of treatment, and end of treatment day. ]
  • Ratio of change in bone age to the change in chronological age. [ Time Frame: Weeks 24 and 48 then every 12 months until end of treatment and end of treatment day. ]
  • Predicted mature height. [ Time Frame: Weeks 24 and 48, then every 12 months until end of treatment, and end of treatment day. ]


Information By: Abbott

Dates:
Date Received: April 15, 2008
Date Started: January 1991
Date Completion:
Last Updated: April 8, 2011
Last Verified: April 2011