Central Precocious Puberty (CPP) Clinical Trial
Official 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
| Verified date | January 2014 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | January 2013 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Site Reference ID/Investigator# 23182 | Bayamon | |
| Puerto Rico | Site Reference ID/Investigator# 21721 | Ponce | |
| Puerto Rico | Site Reference ID/Investigator# 25908 | Rio Piedras | |
| Puerto Rico | Site Reference ID/Investigator# 23082 | San Juan | |
| United States | Site Reference ID/Investigator# 13521 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 22425 | Greenwood Village | Colorado |
| United States | Site Reference ID/Investigator# 16506 | Hershey | Pennsylvania |
| United States | Site Reference ID/Investigator# 26983 | Indianapolis | Indiana |
| United States | Site Reference ID/Investigator# 18181 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 14121 | Kansas City | Missouri |
| United States | Site Reference ID/Investigator# 14922 | Long Beach | California |
| United States | Site Reference ID/Investigator# 26043 | Los Angeles | California |
| United States | Site Reference ID/Investigator# 23643 | Minneapolis | Minnesota |
| United States | Site Reference ID/Investigator# 23802 | Oklahoma City | Oklahoma |
| United States | Site Reference ID/Investigator# 26364 | Pensacola | Florida |
| United States | Site Reference ID/Investigator# 20802 | San Diego | California |
| United States | Site Reference ID/Investigator# 14024 | Seattle | Washington |
| United States | Site Reference ID/Investigator# 20821 | Shreveport | Louisiana |
| United States | Site Reference ID/Investigator# 23502 | St. Paul | Minnesota |
| United States | Site Reference ID/Investigator# 13324 | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | 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. | Day 1, Months 6, 12, 24, and 36 | No |
| Secondary | Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1) | 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. |
Day 1, Months 3, 6, 9, 12, and 24 | No |
| Secondary | Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2) | 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. |
Months 6, 9, 12, 24, 30, and 36 | No |
| Secondary | Percentage of Male Participants With Suppression of Basal Testosterone | 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. | Day 1, Months 3, 6, 9, 12, 24, 30, and 36 | No |
| Secondary | Mean Peak-stimulated Luteinizing Hormone Concentration by Visit | 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. | Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36 | No |
| Secondary | Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) | 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. | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 | No |
| Secondary | Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) | 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. | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 | No |
| Secondary | Change From Baseline in Growth Rate | 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. | 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 | No |
| Secondary | Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age | 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). |
Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03695237 -
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
|
Phase 3 |