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Completed

NCT Number: NCT00660010

Study of Lupron Depot In The Treatment of Central Precocious Puberty

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.

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Key information

Conditions

Puberty, Precocious Endocrine System Diseases Gonadal Disorders

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 46673, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Lupron (leuprolide acetate)

Drug

Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.

Other names: Lupron

Primary outcomes

  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

    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

    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

  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

    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

    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

    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

    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.

Other outcomes

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

    Time frame: 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)

    Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity <1 cm/year or a bone age >14 yrs in females or >15 yrs in males.

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

    Time frame: Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)

    Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment.

  3. Number of Female Subjects Who Reported Regular Menses at Adulthood

    Time frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)

    Subjects were required to complete final adult questionnaire to provide information on adult reproductive function. Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding.

  4. Number of Subjects Who Reported Pregnancies at Final Questionnaire

    Time frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)

    The final questionnaire was completed by 20 females who were at least 18 years of age. The subjects reported on total number of pregnancies resulting in live births or number of miscarriages (spontaneous or elective) and whether the subject was currently pregnant.

  5. Number of Pregnancies Reported by Subjects at Final Questionnaire

    Time frame: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)

    The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start
1991
Primary completion
2009
Study completion
2009
First posted
Apr 17, 2008
Registry last updated
Apr 12, 2011

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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