Active Ingredient History
Megestrol acetate is a progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer. MEGACE Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). The precise mechanism by which megestrol acetate produces effects in anorexia and cachexia is unknown at the present time. But its progestin antitumour activity may involve suppression of luteinizing hormone by inhibition of pituitary function. Studies also suggest that the megestrol's weight gain effect is related to its appetite-stimulant or metabolic effects rather than its glucocorticoid-like effects or the production of edema. It has also been suggested that megestrol may alter metabolic pathyways via interferences with the production or action of mediators such as cachectin, a hormone that inhibits adipocyte lipogenic enzymes. The major route of drug elimination in humans is urine. When radiolabeled megestrol acetate was administered to humans in doses of 4 to 90 mg, the urinary excretion within 10 days ranged from 56.5% to 78.4% (mean 66.4%) and fecal excretion ranged from 7.7% to 30.3% (mean 19.8%). The total recovered radioactivity varied between 83.1% and 94.7% (mean 86.2%). Megestrol acetate metabolites which were identified in urine constituted 5% to 8% of the dose administered. Respiratory excretion as labeled carbon dioxide and fat storage may have accounted for at least part of the radioactivity not found in urine and feces. Plasma steady-state pharmacokinetics of megestrol acetate were evaluated in 10 adult, cachectic male patients with acquired immunodeficiency syndrome (AIDS) and an involuntary weight loss greater than 10% of baseline. Patients received single oral doses of 800 mg/day of MEGACE Oral Suspension for 21 days. Plasma concentration data obtained on day 21 were evaluated for up to 48 hours past the last dose. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Absorption (Phase 1)
Adrenocortical Carcinoma (Phase 2)
Anorexia (Phase 4)
Biological Availability (Phase 1)
Body Weight (Phase 3)
Brain Neoplasms (Phase 2)
Breast Neoplasms (Phase 3)
Cachexia (Phase 4)
Central Nervous System Neoplasms (Phase 2)
Cognitive Dysfunction (Early Phase 1)
Conjunctivitis, Viral (Phase 2)
Dementia (Phase 2/Phase 3)
Endometrial Hyperplasia (Phase 3)
Endometrial Neoplasms (Phase 3)
Esophageal Neoplasms (Phase 3)
Fatigue (Phase 2)
Feeding and Eating Disorders (Phase 4)
Feeding Behavior (Phase 4)
Fertilization in Vitro (Phase 2/Phase 3)
Food (Phase 2)
Head and Neck Neoplasms (Phase 3)
Healthy Volunteers (Phase 1)
HIV Infections (Phase 4)
HIV Wasting Syndrome (Phase 2)
Hot Flashes (Phase 3)
Leukemia (Phase 2)
Liver Neoplasms (Phase 3)
Lung Neoplasms (Phase 3)
Lymphoma (Phase 3)
Mesothelioma, Malignant (Phase 1/Phase 2)
Myelodysplastic Syndromes (Phase 2)
Neoplasms ()
Neoplasms, Second Primary (Phase 4)
Obesity (Phase 2/Phase 3)
Overweight (Phase 2/Phase 3)
Pharmacokinetics (Phase 1)
Puberty (Phase 4)
Pulmonary Disease, Chronic Obstructive (Phase 2)
Quality of Life (Phase 3)
Uterine Neoplasms (Phase 2)
Weight Loss (Phase 3)
| Trial | Phase | Start Date | Organizations | Indications |
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