CLINICAL TRIALS PROFILE FOR OXYMETHOLONE

All Clinical Trials for OXYMETHOLONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00243399 ↗	Oxandrolone for the Treatment of Bone Marrow Aplasia in Fanconi Anemia	Completed	FDA Office of Orphan Products Development	Phase 1	2004-07-01	The purpose of this study is to evaluate the safety of the drug oxandrolone (a type of androgen steroid) in patients with Fanconi anemia (FA), and to determine if this drug can help in the treatment of bone marrow failure in these patients. Androgen steroids are male hormones that can stimulate the production of red blood cells (the cells which carry oxygen in the blood) and platelets (cells that help blood clot).
NCT00243399 ↗	Oxandrolone for the Treatment of Bone Marrow Aplasia in Fanconi Anemia	Completed	Children's Hospital Medical Center, Cincinnati	Phase 1	2004-07-01	The purpose of this study is to evaluate the safety of the drug oxandrolone (a type of androgen steroid) in patients with Fanconi anemia (FA), and to determine if this drug can help in the treatment of bone marrow failure in these patients. Androgen steroids are male hormones that can stimulate the production of red blood cells (the cells which carry oxygen in the blood) and platelets (cells that help blood clot).
NCT01001598 ↗	Safety and Efficacy Trial of Danazol in Patients With Fanconi Anemia or Dyskeratosis Congenita	Terminated	Boston Children's Hospital	Phase 1/Phase 2	2009-11-01	Fanconi anemia (FA) and Dyskeratosis congenita (DC) are inherited bone marrow failure syndromes. The current androgen treatments (e.g., oxymetholone) used to treat FA and DC can cause unwanted masculinizing side effects, indicating a need for a different medication. Danazol is a less potent androgen,and may therefore have fewer masculinizing side effects. Danazol is currently approved by the Food and Drug Administration (FDA) for the treatment of other diseases, but it has never been studied in patients with FA and DC. The main purpose of this study is to see if danazol is a safe treatment for FA and DC. Specifically,we would like to determine: - the best dose of danazol; - how fast hemoglobin (a protein that carries oxygen in the blood) levels rise in FA and DC patients receiving danazol therapy; and - the genetic pattern (known as expression profile) of certain cells in response to danazol, which can predict how well people respond to the medication. Subjects who enroll in the study will be treated with danazol for up to 24 weeks (about 6 months), and will have up to 11 study visits, including followup visits at 38 weeks (9 months) and 52 weeks (one year).
NCT01001598 ↗	Safety and Efficacy Trial of Danazol in Patients With Fanconi Anemia or Dyskeratosis Congenita	Terminated	Boston Children’s Hospital	Phase 1/Phase 2	2009-11-01	Fanconi anemia (FA) and Dyskeratosis congenita (DC) are inherited bone marrow failure syndromes. The current androgen treatments (e.g., oxymetholone) used to treat FA and DC can cause unwanted masculinizing side effects, indicating a need for a different medication. Danazol is a less potent androgen,and may therefore have fewer masculinizing side effects. Danazol is currently approved by the Food and Drug Administration (FDA) for the treatment of other diseases, but it has never been studied in patients with FA and DC. The main purpose of this study is to see if danazol is a safe treatment for FA and DC. Specifically,we would like to determine: - the best dose of danazol; - how fast hemoglobin (a protein that carries oxygen in the blood) levels rise in FA and DC patients receiving danazol therapy; and - the genetic pattern (known as expression profile) of certain cells in response to danazol, which can predict how well people respond to the medication. Subjects who enroll in the study will be treated with danazol for up to 24 weeks (about 6 months), and will have up to 11 study visits, including followup visits at 38 weeks (9 months) and 52 weeks (one year).
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.

Clinical Trial Conditions for OXYMETHOLONE

Condition Name

Condition Name for OXYMETHOLONE
Intervention	Trials
Fanconi Anemia	2
Atrial Fibrillation	1
Dyskeratosis Congenita	1

Condition MeSH

Condition MeSH for OXYMETHOLONE
Intervention	Trials
Fanconi Anemia	2
Anemia	2
Fanconi Syndrome	2
Anemia, Aplastic	1

Clinical Trial Locations for OXYMETHOLONE

Trials by Country

Trials by Country for OXYMETHOLONE
Location	Trials
United States	2
Brazil	1

Trials by US State

Trials by US State for OXYMETHOLONE
Location	Trials
Massachusetts	1
Ohio	1

Clinical Trial Progress for OXYMETHOLONE

Clinical Trial Phase

Clinical Trial Phase for OXYMETHOLONE
Clinical Trial Phase	Trials
Phase 4	1
Phase 1/Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for OXYMETHOLONE
Clinical Trial Phase	Trials
Completed	2
Terminated	1

Clinical Trial Sponsors for OXYMETHOLONE

Sponsor Name

Sponsor Name for OXYMETHOLONE
Sponsor	Trials
FDA Office of Orphan Products Development	1
Children's Hospital Medical Center, Cincinnati	1
Boston Children's Hospital	1

Sponsor Type

Sponsor Type for OXYMETHOLONE
Sponsor	Trials
Other	5
U.S. Fed	1