Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.
NCT03277690 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Levoketoconazole
Study Locations (20)
Other
- Alexandovska University Hospital, Clinic of Endocrinology & Metabolic Diseases — Sofia
- University Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD Clinic of Endocrinology and Metabolic Diseases — Sofia
- University Specialized Hospital for Active Treatment in Endocrinology (USHATE) I Klinika — Sofia
- Rigshospitalet, Copenhagen University Hospital, Endocrinology Department — Copenhagen
- Evangelismos Athens General Hospital, Department of Endocrinology — Athens
- General Hospital of Athens 'G. Gennimatas', Department of Endocrinology-Diabetes Centre — Athens
California
- Keck Medical Center University of Southern California HCII, Internal Medicine - Keck Hospital — Los Angeles
- Cedars-Sinai Medical Center, Cedars-Sinai Pituitary Center — Los Angeles
- UCLA School of Medicine, Medicine/Endocrinology Department — Los Angeles
New York
- Columbia University, College of P&S Medicine/Neuro-endocrine Unit — New York
- Memorial Sloan Kettering Cancer Center, Endocrinology — New York
Florida
- The Center for Diabetes and Endocrine Care — Fort Lauderdale
Georgia
- Emory University, Neurosurgery — Atlanta
Illinois
- Northwestern University, Medicine - Endocrinology — Chicago
Maryland
- Johns Hopkins University, Endocrinology Department — Baltimore
Michigan
- University of Michigan, Comprehensive Endocrine Research, Internal Medicine - MEND — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2020-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03277690
The ClinicalTrials.gov registry entry for NCT03277690 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cortendo AB, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Endogenous Cushing's Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03277690 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03277690 about?
NCT03277690 is a clinical study titled "A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.". 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...
What is the current status of trial NCT03277690?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2017-09-26. Estimated completion is 2020-08-31.
What conditions does trial NCT03277690 study?
This clinical trial studies the following conditions: Endogenous Cushing's Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03277690?
The interventions under investigation include: Placebo (DRUG), Levoketoconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03277690?
This trial is sponsored by Cortendo AB, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03277690 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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