Trial · NCT03277690

A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

NCT03277690, Phase 3, Completed, Cortendo AB; results first posted 2022-11-08

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. Trials, record NCT03277690. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03277690

On this page

Trial

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

Title: A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.
NCT number: NCT03277690
Status: Completed
Phases: Phase 3
Enrollment: 84 participants, actual
Lead sponsor: Cortendo AB
Conditions: Endogenous Cushing's Syndrome
Interventions: Levoketoconazole, Placebo
First posted: 2017-09-11
Last updated: 2022-11-08
Results first posted: 2022-11-08

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.	max. 9.5 weeks	Urinary free cortisol (UFC) level measurement: Loss of therapeutic response is inferred based on mUFC from three 24-hour UFC measurements obtained at any visit from second through final Randomized Withdrawal Phase visits (RW1 through RW5 inclusive) when: (1) mUFC is above 1.5X the ULN of the central laboratory's reference range, OR (2) mUFC is more than 40% above the baseline (RW0) value, if the RW0 value is above the ULN (i.e. \>1.0X ULN)1, OR (3) an early rescue criterion is met.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.	max. 9.5 weeks	Intent to Treat (ITT)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.	Levoketoconazole		9		Participants
Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.	Placebo		21		Participants

Source ClinicalTrials.gov

Participant flow26

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

Period	Milestone	Group	Participants
Dose Titration and Maintenance	STARTED	Levoketoconazole	79
Dose Titration and Maintenance	STARTED	Placebo	0
Dose Titration and Maintenance	COMPLETED	Levoketoconazole	39
Dose Titration and Maintenance	COMPLETED	Placebo	0
Dose Titration and Maintenance	NOT COMPLETED	Levoketoconazole	40
Dose Titration and Maintenance	NOT COMPLETED	Placebo	0
Randomized Withdrawal	STARTED	Levoketoconazole	22
Randomized Withdrawal	STARTED	Placebo	22
Randomized Withdrawal	Subjects Which Were Previous Levoketoconazole Study Completers	Levoketoconazole	1
Randomized Withdrawal	Subjects Which Were Previous Levoketoconazole Study Completers	Placebo	4

1 to 10 of 26Source ClinicalTrials.gov

See all 26 participant flow

Adverse events231

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
other	Nausea	Gastrointestinal disorders	Levoketoconazole-ITT RW Phase	2	22
other	Nausea	Gastrointestinal disorders	Placebo- ITT RW Phase	1	22
other	Nausea	Gastrointestinal disorders	Safety Population	24	84
other	Abdominal distension	Gastrointestinal disorders	Levoketoconazole-ITT RW Phase	0	22
other	Abdominal distension	Gastrointestinal disorders	Placebo- ITT RW Phase	1	22
other	Abdominal distension	Gastrointestinal disorders	Safety Population	0	84
other	Constipation	Gastrointestinal disorders	Levoketoconazole-ITT RW Phase	1	22
other	Constipation	Gastrointestinal disorders	Placebo- ITT RW Phase	0	22
other	Constipation	Gastrointestinal disorders	Safety Population	5	84
other	Diarrhoea	Gastrointestinal disorders	Levoketoconazole-ITT RW Phase	1	22

1 to 10 of 231Source ClinicalTrials.gov

See all 231 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Levoketoconazole-ITT RW Phase	0	22
Total, all-cause mortality	Placebo- ITT RW Phase	0	22
Total, all-cause mortality	Safety Population	0	84
Total, other adverse events	Levoketoconazole-ITT RW Phase	11	22
Total, other adverse events	Placebo- ITT RW Phase	10	22
Total, other adverse events	Safety Population	73	84
Total, serious adverse events	Levoketoconazole-ITT RW Phase	1	22
Total, serious adverse events	Placebo- ITT RW Phase	0	22
Total, serious adverse events	Safety Population	13	84

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 comparisons1

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

Comparison
Levoketoconazole vs Placebo: Number of Subjects With Loss of Therapeutic Response to Levoketoconazole Upon Withdrawing to Placebo Compared With the Proportion of Subjects With Loss of Therapeutic Response Upon Continuing Treatment With Levoketoconazole.

Source Trial comparisons

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.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone 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/NCT03277690

GET https://conductscience.org/api/trials/v1/NCT03277690/flow?page=2

API reference For AI assistants