Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis] (BATT)
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|ClinicalTrials.gov Identifier: NCT00094328|
Recruitment Status : Completed
First Posted : October 18, 2004
Results First Posted : July 9, 2009
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Puberty, Precocious||Drug: Bicalutamide Drug: Anastrozole||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination With Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys With Testotoxicosis|
|Actual Study Start Date :||November 22, 2004|
|Actual Primary Completion Date :||May 22, 2008|
|Actual Study Completion Date :||December 6, 2017|
Bicalutamide with Anastrozole
Bicalutamide in combination with Anastrozole
Other Name: Casodex
- Change in Growth Rate (cm/Year) [ Time Frame: Assessed after 12 months treatment ]Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).
- Change in Growth Rate (SD Units) [ Time Frame: Assessed after 12 months treatment ]Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score).
- Change in Growth Rate (cm/Year) [ Time Frame: Assessed after 6 months treatment ]Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period.
- Change in Growth Rate (SD Units) [ Time Frame: Assessed after 6 months treatment ]Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period.
- Change in Bone Age Maturation Rate (cm/Year) [ Time Frame: Assessed after 6 and 12 months treatment ]Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation after 6 months of treatment was calculated relative to the rate of change in bone age during the ≥ 6 months pre-study period.
- Change in Bone Age to Chronological Age Ratio [ Time Frame: Assessed after 6 and 12 months of treatment ]Change in bone age to chronological age ratio after 6 and 12 months treatment relative to the baseline ratio for all patients.
- Number of Patients With Height Between 5th and 95th Percentile [ Time Frame: Assessed after 3, 6, 9 and 12 months of treatment ]The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.
- Change in Predicted Adult Height (PAH) [ Time Frame: Assessed after 12 months treatment ]Radiographs are used to assess the bone age, the change in predicted adult height (PAH) is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH is be calculated by subtracting the PAH at baseline from the PAH at 12 months.
- Change in Average Testicular Volume [ Time Frame: Assessed after 6 and 12 months of treatment ]Testicular volume of both testes was measured using either ultrasound or an orchidometer. Testicular volume was measured at baseline and at 6 and 12 months. The change in testicular volume from baseline was calculated for the left and right testicle as well as the average across both testes by subtracting the baseline volume from the volumes at 6 and 12 months within each patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094328
|United States, Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Florida|
|Jacksonville, Florida, United States, 32207|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55416|
|United States, Oklahoma|
|Tulsa, Oklahoma, United States, 74136|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19134|
|United States, South Carolina|
|Greenville, South Carolina, United States, 29615|
|United States, Texas|
|Temple, Texas, United States, 76508|
|United States, Washington|
|Spokane, Washington, United States, 99204|
|London, Ontario, Canada, N6A 4G5|
|Montpellier Cedex, France, 34295|
|Chennai, India, 600020|
|New Dehli, India, 110029|
|Moscow, Russian Federation, 117036|
|London, United Kingdom, WC1N 3JH|
|Study Director:||Yuri E Rukazenkov, MD||AstraZeneca|