CLINICAL TRIALS PROFILE FOR OXYMETHOLONE
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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). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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