Trial · NCT00094328
Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
NCT00094328, Phase 2, Completed, AstraZeneca; results first posted 2009-07-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]. Trials, record NCT00094328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00094328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
- NCT number
- NCT00094328
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Puberty, Precocious
- Interventions
- Bicalutamide, Anastrozole
- First posted
- 2004-10-18
- Last updated
- 2018-06-26
- Results first posted
- 2009-07-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Growth Rate (cm/Year) | 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). |
| Primary | Change in Growth Rate (SD Units) | 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). |
| Secondary | Change in Growth Rate (cm/Year) | 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. |
| Secondary | Change in Growth Rate (SD Units) | 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. |
| Secondary | Change in Bone Age Maturation Rate (cm/Year) | 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. |
| Secondary | Change in Bone Age to Chronological Age Ratio | 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. |
| Secondary | Number of Patients With Height Between 5th and 95th Percentile | 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. |
| Secondary | Change in Predicted Adult Height (PAH) | 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. |
| Secondary | Change in Average Testicular Volume | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Growth Rate (cm/Year) | Assessed after 12 months treatment | All treated (AT) set | cm/year | MEAN |
| PRIMARY | Change in Growth Rate (SD Units) | Assessed after 12 months treatment | All treated (AT) set | SD units | MEAN |
| SECONDARY | Change in Growth Rate (cm/Year) | Assessed after 6 months treatment | All treated (AT) set | cm/year | MEAN |
| SECONDARY | Change in Growth Rate (SD Units) | Assessed after 6 months treatment | All treated (AT) set | SD units | MEAN |
| SECONDARY | Change in Bone Age Maturation Rate (cm/Year) | Assessed after 6 and 12 months treatment | Calculated on All treated analysis set for those patients who had a 6-month pre study radiograph. | cm/year | MEAN |
| SECONDARY | Change in Bone Age to Chronological Age Ratio | Assessed after 6 and 12 months of treatment | All treated (AT) set | Ratio | MEAN |
| SECONDARY | Number of Patients With Height Between 5th and 95th Percentile | Assessed after 3, 6, 9 and 12 months of treatment | All treated (AT) set | Participants | NUMBER |
| SECONDARY | Change in Predicted Adult Height (PAH) | Assessed after 12 months treatment | Calculated on All treated analysis set, however, if bone age is less than 6 years or bone age is less than 7 years and bone age\>=(chronological age-1) then PAH cannot be calculated using the Bayley and Pinneau method. | cm | MEAN |
| SECONDARY | Change in Average Testicular Volume | Assessed after 6 and 12 months of treatment | All treated (AT) set | mL | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Growth Rate (cm/Year) | Open Label Bicalutamide With Anastrozole | -1.62 | Standard Deviation 5.13 | cm/year | |
| Change in Growth Rate (SD Units) | Open Label Bicalutamide With Anastrozole | -0.07 | Standard Deviation 1.78 | SD units | |
| Change in Growth Rate (cm/Year) | Open Label Bicalutamide With Anastrozole | -0.70 | Standard Deviation 5.77 | cm/year | |
| Change in Growth Rate (SD Units) | Open Label Bicalutamide With Anastrozole | -0.14 | Standard Deviation 1.67 | SD units | |
| Change in Bone Age Maturation Rate (cm/Year) | Open Label Bicalutamide With Anastrozole | After 6 months treatment | -2.03 | Standard Deviation 0.38 | cm/year |
| Change in Bone Age Maturation Rate (cm/Year) | Open Label Bicalutamide With Anastrozole | After 12 months treatment | -2.29 | Standard Deviation 0.51 | cm/year |
| Change in Bone Age to Chronological Age Ratio | Open Label Bicalutamide With Anastrozole | After 6 months treatment | -0.09 | Standard Deviation 0.14 | Ratio |
| Change in Bone Age to Chronological Age Ratio | Open Label Bicalutamide With Anastrozole | After 12 months treatment | -0.24 | Standard Deviation 0.18 | Ratio |
| Number of Patients With Height Between 5th and 95th Percentile | Open Label Bicalutamide With Anastrozole | After 3 months treatment | 3 | Participants | |
| Number of Patients With Height Between 5th and 95th Percentile | Open Label Bicalutamide With Anastrozole | After 6 months treatment | 3 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open Label Bicalutamide With Anastrozole | 14 | |
| Overall Study | COMPLETED | Open Label Bicalutamide With Anastrozole | 13 | |
| Overall Study | NOT COMPLETED | Open Label Bicalutamide With Anastrozole | 1 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Open Label Bicalutamide With Anastrozole | 2 | 14 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Open Label Bicalutamide With Anastrozole | 1 | 14 | |
| other | Acne | Skin and subcutaneous tissue disorders | Open Label Bicalutamide With Anastrozole | 2 | 14 | |
| other | Alanine Aminotransferase Increased | Investigations | Open Label Bicalutamide With Anastrozole | 1 | 14 | |
| other | Aspartate Aminotransferase Increased | Investigations | Open Label Bicalutamide With Anastrozole | 1 | 14 | |
| other | Asthenia | General disorders | Open Label Bicalutamide With Anastrozole | 1 | 14 | |
| other | Breast Pain | Reproductive system and breast disorders | Open Label Bicalutamide With Anastrozole | 1 | 14 | |
| other | Breast Tenderness | Reproductive system and breast disorders | Open Label Bicalutamide With Anastrozole | 2 | 14 | |
| other | Cafe Au Lait Spots | Skin and subcutaneous tissue disorders | Open Label Bicalutamide With Anastrozole | 1 | 14 | |
| other | Conjunctivitis | Eye disorders | Open Label Bicalutamide With Anastrozole | 2 | 14 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label Bicalutamide With Anastrozole | 0 | 14 |
| Total, other adverse events | Open Label Bicalutamide With Anastrozole | 13 | 14 |
| Total, serious adverse events | Open Label Bicalutamide With Anastrozole | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00094328
GET https://conductscience.org/api/trials/v1/NCT00094328/events?page=2