Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis] (BATT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00094328 |
Recruitment Status
:
Completed
First Posted
: October 18, 2004
Results First Posted
: July 9, 2009
Last Update Posted
: March 14, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Bicalutamide with Anastrozole
Bicalutamide in combination with Anastrozole
|
Drug: Bicalutamide
oral
Other Name: Casodex
Drug: Anastrozole
oral
Other Names:
|
- 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 Bone Maturation Rate [ Time Frame: Assessed after 12 months treatment ]Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 months 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 was calculated from this rate and that calculated at 12 months.
- Normalization of Growth Rate [ Time Frame: Assessed after 12 months 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 will be used to assess the bone age, the PAH is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH will be calculated by subtracting the PAH at baseline from the PAH at 12 months.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 13 Years (Child) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provision of written informed consent of parent/legal guardian and subject assent (as needed by local requirements)
- Male aged 2 years and over
- Diagnosis of testotoxicosis based on the following:
- Clinical features of Progressive sexual precocity documented by Tanner staging and evidence of symmetrical testicular enlargement
- Clinical features of significantly advanced bone age (defined as bone age of at least 12 months beyond chronological age)
- Pubertal levels of serum testosterone
- Prepubertal levels of serum gonadotropins
- Lack of an increase in serum gonadotropin levels following GnRH stimulation
- Other pathology excluded by:
- Undetectable plasma b human chorionic gonadotropin (bHCG). Samples with values below the LOQ will be reported as "<10 IU/L" which in the clinical setting equate to 'undetectable'.
- Normal levels of 17-hydroxyprogesterone (17-OHP)
- Normal levels of dehydroepiandrosterone sulphate (DHEAS)
- Naive to anti androgen receptor therapy:
(Note: Ketoconazole and Spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors)
- A documented reliable height measurement taken > 6 months prior to study enrollment. Additionally for subjects who have previously received ketoconazole or spironolactone treatment, a documented reliable height measurement taken immediately prior to beginning this treatment.
(Note: for subjects who received such previous treatment only a single assessment is needed if it was taken immediately prior to beginning treatment and > 6 months prior to study entry)
- Subjects should be free of endocrine or other effects of previous treatment for testotoxicosis prior to study entry: to ensure this there should be 15 days or 4 drug half lives (whichever is the longer) washout period from prior medication for testotoxicosis.
Exclusion Criteria:
- Evidence of central precocious puberty as demonstrated by GnRH stimulation test
- Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5 times the upper limit of normal for age
- Serum concentration of creatinine greater than 1.5 times the upper limit of normal for age
- 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
- Known hypersensitivity to any of the study medications
- Participation in a clinical study at the time of enrollment

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 | |
Research Site | |
Birmingham, Alabama, United States, 35233 | |
United States, Florida | |
Research Site | |
Jacksonville, Florida, United States, 32207 | |
United States, Indiana | |
Research Site | |
Indianapolis, Indiana, United States, 46202 | |
United States, Minnesota | |
Research Site | |
Minneapolis, Minnesota, United States, 55416 | |
United States, Oklahoma | |
Research Site | |
Tulsa, Oklahoma, United States, 74136 | |
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States, 19134 | |
United States, South Carolina | |
Research Site | |
Greenville, South Carolina, United States, 29615 | |
United States, Texas | |
Research Site | |
Temple, Texas, United States, 76508 | |
United States, Washington | |
Research Site | |
Spokane, Washington, United States, 99204 | |
Canada, Ontario | |
Research Site | |
London, Ontario, Canada, N6A 4G5 | |
France | |
Research Site | |
Montpellier Cedex, France, 34295 | |
India | |
Research Site | |
Chennai, India, 600020 | |
Research Site | |
New Dehli, India, 110029 | |
Russian Federation | |
Research Site | |
Moscow, Russian Federation, 117036 | |
United Kingdom | |
Research Site | |
London, United Kingdom, WC1N 3JH |
Study Director: | Yuri E Rukazenkov, MD | AstraZeneca |
Additional Information:
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00094328 History of Changes |
Other Study ID Numbers: |
D6873C00047 BATT |
First Posted: | October 18, 2004 Key Record Dates |
Results First Posted: | July 9, 2009 |
Last Update Posted: | March 14, 2018 |
Last Verified: | January 2018 |
Keywords provided by AstraZeneca:
Testotoxicosis Familial Male-limited Precocious Puberty (FMPP) |
Additional relevant MeSH terms:
Puberty, Precocious Gonadal Disorders Endocrine System Diseases Anastrozole Bicalutamide Antineoplastic Agents, Hormonal Antineoplastic Agents Aromatase Inhibitors |
Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Androgen Antagonists |