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

ClinicalTrials.gov ID: NCT03277690

Public ClinicalTrials.gov record NCT03277690. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.

Study identification

NCT ID: NCT03277690
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Cortendo AB; Industry
Enrollment: 84 participants

Conditions and interventions

Conditions

Endogenous Cushing's Syndrome

Interventions

Levoketoconazole Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 26, 2017 (Actual)
Primary completion: Jun 30, 2020 (Actual)
Completion: Aug 31, 2020 (Actual)
Last update posted: Nov 8, 2022

2017 – 2020

United States locations

U.S. sites: 13
U.S. states: 10
U.S. cities: 10

Facility	City	State	ZIP	Site status
Keck Medical Center University of Southern California HCII, Internal Medicine - Keck Hospital	Los Angeles	California	90033	—
Cedars-Sinai Medical Center, Cedars-Sinai Pituitary Center	Los Angeles	California	90048	—
UCLA School of Medicine, Medicine/Endocrinology Department	Los Angeles	California	90095	—
The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida	33312	—
Emory University, Neurosurgery	Atlanta	Georgia	30322	—
Northwestern University, Medicine - Endocrinology	Chicago	Illinois	60611	—
Johns Hopkins University, Endocrinology Department	Baltimore	Maryland	21287	—
University of Michigan, Comprehensive Endocrine Research, Internal Medicine - MEND	Ann Arbor	Michigan	48109	—
Washington University School of Medicine, Endocrinology	St Louis	Missouri	63110	—
Columbia University, College of P&S Medicine/Neuro-endocrine Unit	New York	New York	10032	—
Memorial Sloan Kettering Cancer Center, Endocrinology	New York	New York	10065	—
Oregon Health & Science University, Neurological Surgery	Portland	Oregon	97239	—
Allegheny Neuroendocrinology Center, West Penn Allegheny Health System	Pittsburgh	Pennsylvania	15212	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03277690, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 8, 2022 · Synced Oct 25, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03277690 live on ClinicalTrials.gov.

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