Trial · NCT00348946

Androgen Effect on Klinefelter Syndrome Motor Outcome

NCT00348946, Phase 2, Completed, Thomas Jefferson University; results first posted 2021-07-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Androgen Effect on Klinefelter Syndrome Motor Outcome. Trials, record NCT00348946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00348946

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Androgen Effect on Klinefelter Syndrome Motor Outcome
NCT number: NCT00348946
Status: Completed
Phases: Phase 2
Enrollment: 93 participants, actual
Lead sponsor: Thomas Jefferson University
Conditions: Klinefelter Syndrome
Interventions: androgen oxandrolone, placebo
First posted: 2006-07-06
Last updated: 2021-07-08
Results first posted: 2021-07-08

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Motor Function/Strength	2 years per subject	Outcome measures were tested using the following assessments: Bruininks-Osertesky Test of Motor Proficiency (BOT) subscales of (1) Visual Motor Control, (2) Upper limb Speed, and (3) Strength, Physical and Neurological Evaluation for Soft Signs (PANESS), and Hand Strength Dynamometer. BOT assess the child's motor development and includes standard scores (mean=100, SD=15) and subtest scores and is normed for sex and age (4-14.5 years). PANESS assesses the time required to press thumb to 4 fingers 20 times for the dominant and nondominant hands and includes standard scores (mean=100, SD=15) with age-specific norms (4-18 years). Hand strength dynamometer assess hand strength in the dominant and nondominant hands and includes standard scores (mean=100, SD=15). Data is expressed as standard scores with mean of 100 and SD of 15. The minimum standard score is 50; the maximum standard score is 145. Higher scorers imply better function.
Secondary	Cognitive Function and Language	2 years per subject	Outcome measures were tested using the Differential Ability Scales - 2nd edition (DAS-II). DAS-II provides an age- and sex-standardized assessment of intellectual functioning (General Concept Ability subscale similar to IQ) in children ages 2-17 years of age (mean=100, SD=15). The Verbal Cluster measures the child's ability to define words and perform verbal reasoning tasks. The Nonverbal Cluster measures the child's inductive and sequential reasoning abilities. The Spatial Cluster measures visuospatial construction ability, spatial memory, and spatial reasoning. Data is expressed as standard scores with mean of 100 and SD of 15. The minimum standard score is 50; the maximum standard score is 145. Higher scores imply better function.
Secondary	Working Memory/Attention	2 years per participant	Outcome measures were tested using the following cognitive assessments: Digit Span Backward, A Neuropsychological Assessment (NEPSY) subscales of (1) Phonemic Fluency and (2) Semantic Fluency, and Connors' Continuous Performance Test (CPT-II) subscales (1) Omissions, (2) Commissions, (3) Hit Reaction, (4) Variability, and (5) Preservations. Digit Span Backward tests working memory and is normed for children ages 5-16 years. Phonemic Fluency measures the number of words that the child can name beginning with the letters F and S (ages 6-12). Semantic Fluency measures the number of words the child can name in the categories food and drink (ages 4-12). CPT-II measures the ability to maintain attention over an extended period of time. All scores are reported as standard scores with a mean of 100 and SD of 15. The minimum standard score is 50; the maximum standard score is 145. Higher scores imply better function.
Secondary	Psychosocial and Behavior Domain	2 years per participants	Outcome measures were tested using the following social assessments: The Child Behavior Checklist (CBCL) and The Children's Depression Inventory (CDI). The CBCL is standardized measure of behavior problems and social competency normed for children ages 4-16. Higher scores indicate more problems, with the cutoff for the clinical range at a t score greater than or equal to 67. The CDI assess cognitive, affective and behavioral signs of depression in children ages 6-17. The CDI total score reflects the presence of overall depressive symptoms. All scores are expressed as t-scores with a mean of 50 and SD of 10. Lower scores imply better function and higher scores indicate more problem behaviors.
Secondary	Psychosocial and Behavior Domain	2 years per subject	Outcome measures were tested using The Piers-Harris Self Concept Scale. Scoring provides a total standard score and scores on six subscales: physical appearance and attributes, freedom from anxiety, intellectual and school status, behavioral adjustment, happiness and satisfaction, and popularity. Subscales are summed and standardized to provide the total standard score with a mean of 100 and SD of 15. The minimum standard score is 50; the maximum standard score is 145. Higher scores imply better function.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Motor Function/Strength	2 years per subject	Some participants were not able to complete all test and/or it was determined by the investigator that their results do reflect their ability and they were removed from the analysis.	score on a scale	MEAN
SECONDARY	Cognitive Function and Language	2 years per subject		score on a scale	MEAN
SECONDARY	Working Memory/Attention	2 years per participant	Some participants were not able to complete all assessments and/or it was determined by the investigator that their results do reflect their ability and they were removed from the analysis .	score on a scale	MEAN
SECONDARY	Psychosocial and Behavior Domain	2 years per participants	Some participants were not able to complete all assessments and/or it was determined by the investigator that their results do reflect their ability and they were removed from the analysis.	score on a scale	MEAN
SECONDARY	Psychosocial and Behavior Domain	2 years per subject		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Motor Function/Strength	Oxandrolone	BOT Visual-motor control SS	86	Standard Deviation 1	score on a scale
Motor Function/Strength	Placebo	BOT Visual-motor control SS	81	Standard Deviation 1	score on a scale
Motor Function/Strength	Oxandrolone	BOT Upper limb speed SS	92	Standard Deviation 1	score on a scale
Motor Function/Strength	Placebo	BOT Upper limb speed SS	89	Standard Deviation 2	score on a scale
Motor Function/Strength	Oxandrolone	BOT Strength SS	88	Standard Deviation 1	score on a scale
Motor Function/Strength	Placebo	BOT Strength SS	85	Standard Deviation 1	score on a scale
Motor Function/Strength	Oxandrolone	Hand Dynamometer SS- dominant hand	123	Standard Deviation 2	score on a scale
Motor Function/Strength	Placebo	Hand Dynamometer SS- dominant hand	118	Standard Deviation 2	score on a scale
Motor Function/Strength	Oxandrolone	PANESS SS- dominant hand	91	Standard Deviation 3	score on a scale
Motor Function/Strength	Placebo	PANESS SS- dominant hand	91	Standard Deviation 3	score on a scale

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oxandrolone	46
Overall Study	STARTED	Placebo	47
Overall Study	COMPLETED	Oxandrolone	35
Overall Study	COMPLETED	Placebo	35
Overall Study	NOT COMPLETED	Oxandrolone	11
Overall Study	NOT COMPLETED	Placebo	12

Source ClinicalTrials.gov

Adverse events24

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	Musculoskeletal complaints	Musculoskeletal and connective tissue disorders	Oxandrolone	29	46	54
other	Musculoskeletal complaints	Musculoskeletal and connective tissue disorders	Placebo	29	47	53
other	Infections (any)	Infections and infestations	Oxandrolone	36	46	77
other	Infections (any)	Infections and infestations	Placebo	38	47	77
other	Headache	Nervous system disorders	Oxandrolone	21	46	56
other	Headache	Nervous system disorders	Placebo	22	47	42
other	Seizure	Nervous system disorders	Oxandrolone	1	46	1
other	Seizure	Nervous system disorders	Placebo	0	47	0
other	Emergency room visits - Musculoskeletal	Musculoskeletal and connective tissue disorders	Oxandrolone	5	46	5
other	Emergency room visits - Musculoskeletal	Musculoskeletal and connective tissue disorders	Placebo	2	47	2

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxandrolone	0	46
Total, all-cause mortality	Placebo	0	47
Total, other adverse events	Oxandrolone	36	46
Total, other adverse events	Placebo	38	47
Total, serious adverse events	Oxandrolone	0	46
Total, serious adverse events	Placebo	0	47

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27637014	DERIVED	PubMed
28285751	DERIVED	PubMed
29931143	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01NS050597	Androgen effect on motor/cognitive outcome in Klinefelter syndrome	ROSS, JUDITH L	THOMAS JEFFERSON UNIVERSITY	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2006 to 2010

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Oxandrolone vs Placebo: deaths from any cause	Trial comparisons
Oxandrolone vs Placebo: serious adverse events	Trial comparisons

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Category Fluency	Secondary outcome	ConductCognition
Continuous Performance Test	Secondary outcome	ConductCognition
Digit Span Test	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00348946

GET https://conductscience.org/api/trials/v1/NCT00348946/results?page=2

API reference For AI assistants