Trial · NCT02574910

Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1

NCT02574910, Phase 1, Terminated, University of Texas Southwestern Medical Center; results first posted 2025-11-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1. Trials, record NCT02574910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02574910

On this page

Trial

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

Title: Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1
NCT number: NCT02574910
Status: Terminated
Phases: Phase 1
Enrollment: 4 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Congenital Adrenal Hyperplasia
Interventions: Abiraterone acetate
First posted: 2015-10-14
Last updated: 2025-11-04
Results first posted: 2025-11-04
Limitations and caveats: Enrollment was adversely impacted by study drug availability, requiring reformulation; by the COVID19 pandemic; by competing industry sponsored Phase 2-3 trials of tildacerfont and crinecerfont, which targeted the same outcome in the same population; and by the eventual FDA approval of crinecerfont.

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Normalization of Serum Androstenedione Level	7 days	The original primary endpoint was the dose of abiraterone acetate that normalized androstenedione to age-appropriate levels in 7/8 subjects after 7 days of treatment. However, an insufficient number of participants was enrolled to evaluate the primary endpoint. Therefore, we have instead presented the number of participants at each dose level who did normalize androstenedione to age-appropriate levels.
Secondary	17-hydroxyprogestoerone Levels	7 days	Final lab results at Screening and V6. This outcome is not pre-specified in the protocol and was inadvertently added at the time of registration.
Secondary	Area Under the Plasma Concentration Versus Time Curve (AUC) of Abiraterone	7 days	Sparse pharmacokinetic (PK) will be derived from peak and trough abiraterone levels.
Secondary	Peak Plasma Concentration (Cmax)	7 days	Sparse pharmacokinetic (PK) will be derived from peak and trough abiraterone levels.
Other	Dihydrotestosterone Levels	7 days	Final lab results at Screening and V6. This was erroneously listed as a secondary outcome in PRS. We have changed the outcome measure type to "Other pre-specified." .
Other	Number of Adverse Events	7 days	Safety monitoring in Phase 1 will include liver function tests (AST, Alanine Aminotransferease (ALT), bilirubin) and possible mineralocorticoid effects (blood pressure, plasma renin).

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Normalization of Serum Androstenedione Level	7 days	No subjects enrolled at 4 mg/kg/d	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	17-hydroxyprogestoerone Levels	7 days	Due to early termination of this study and incomplete enrollment, the collected data are incomplete and limited. These collected samples will never be analyzed in the future. Due to quality issues with the resulting of 17-hydroxyprogestoerone, there is one per-protocol patient to report this result on.	ng/dL	NUMBER
SECONDARY	Area Under the Plasma Concentration Versus Time Curve (AUC) of Abiraterone	7 days	The values for this outcome measurement were not collected and we have no data relating to PK to report because the collected samples were not processed for this outcome measure and will never be processed in the future as well.
SECONDARY	Peak Plasma Concentration (Cmax)	7 days	The values for this outcome measurement were not collected and we have no data relating to PK to report because the collected samples were not processed for this outcome measure and will never be processed in the future as well.
OTHER_PRE_SPECIFIED	Dihydrotestosterone Levels	7 days	Due to early termination of this study and incomplete enrollment, the collected data are incomplete and limited, it is not considered valid to perform this outcome measure assessment and therefore unable to analyze and report it.
OTHER_PRE_SPECIFIED	Number of Adverse Events	7 days	No participants enrolled at the 4 mg/kg/d level.	events	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Units
Normalization of Serum Androstenedione Level	Abiraterone acetate 1 mg/kg/d	0	Participants
Normalization of Serum Androstenedione Level	Abiraterone acetate 2 mg/kg/d	1	Participants
Normalization of Serum Androstenedione Level	Abiraterone acetate 4 mg/kg/d	0	Participants
17-hydroxyprogestoerone Levels	Abiraterone acetate 1 mg/kg/d	-2790	ng/dL
Number of Adverse Events	Abiraterone acetate 1 mg/kg/d	6	events
Number of Adverse Events	Abiraterone acetate 2 mg/kg/d	1	events

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Abiraterone acetate 1 mg/kg/d	2
Overall Study	STARTED	Abiraterone acetate 2 mg/kg/d	2
Overall Study	STARTED	Abiraterone acetate 4 mg/kg/d	0
Overall Study	COMPLETED	Abiraterone acetate 1 mg/kg/d	2
Overall Study	COMPLETED	Abiraterone acetate 2 mg/kg/d	2
Overall Study	COMPLETED	Abiraterone acetate 4 mg/kg/d	0
Overall Study	NOT COMPLETED	Abiraterone acetate 1 mg/kg/d	0
Overall Study	NOT COMPLETED	Abiraterone acetate 2 mg/kg/d	0
Overall Study	NOT COMPLETED	Abiraterone acetate 4 mg/kg/d	0

Source ClinicalTrials.gov

Adverse events15

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	Headache	Nervous system disorders	Abiraterone acetate 1 mg/kg/d	1	2	2
other	Headache	Nervous system disorders	Abiraterone acetate 2 mg/kg/d	0	2	0
other	Headache	Nervous system disorders	Abiraterone acetate 4 mg/kg/d	0	0	0
other	vomiting	Gastrointestinal disorders	Abiraterone acetate 1 mg/kg/d	1	2	2
other	vomiting	Gastrointestinal disorders	Abiraterone acetate 2 mg/kg/d	1	2	1
other	vomiting	Gastrointestinal disorders	Abiraterone acetate 4 mg/kg/d	0	0	0
other	Fever	General disorders	Abiraterone acetate 1 mg/kg/d	1	2	1
other	Fever	General disorders	Abiraterone acetate 2 mg/kg/d	0	2	0
other	Fever	General disorders	Abiraterone acetate 4 mg/kg/d	0	0	0
other	abrasion	Skin and subcutaneous tissue disorders	Abiraterone acetate 1 mg/kg/d	1	2	1

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Abiraterone acetate 1 mg/kg/d	0	2
Total, all-cause mortality	Abiraterone acetate 2 mg/kg/d	0	2
Total, all-cause mortality	Abiraterone acetate 4 mg/kg/d	0	0
Total, other adverse events	Abiraterone acetate 1 mg/kg/d	2	2
Total, other adverse events	Abiraterone acetate 2 mg/kg/d	1	2
Total, other adverse events	Abiraterone acetate 4 mg/kg/d	0	0
Total, serious adverse events	Abiraterone acetate 1 mg/kg/d	0	2
Total, serious adverse events	Abiraterone acetate 2 mg/kg/d	0	2
Total, serious adverse events	Abiraterone acetate 4 mg/kg/d	0	0

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24780050	BACKGROUND

Source 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
U01HD083493	Abiraterone Acetate in Childen with Classic 21-Hydroxylase Deficiency	WHITE, PERRIN C	UT SOUTHWESTERN MEDICAL CENTER	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2015 to 2020

Source NIH RePORTER

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.

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/NCT02574910

GET https://conductscience.org/api/trials/v1/NCT02574910/registered

API reference For AI assistants