A pilot study of the medroxyprogesterone + metformin combination therapy for the endometrial cancer

UMIN ID: UMIN000002210

Registered date:16/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: endometrial cancer atypical endometrial hyperplasia
• Date of first enrollment: 2009/02/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients were scheduled to received 400mg per day of medroxyprogesterone acetate with 100mg of aspirin orally on a daily basis for 24weeks. The metformin combines concurrently. We administer the metformin from start 750mg per day and increase in quantity to 2,250mg per day without a side effect The patients take metformin continuously for four years

Outcome(s)

• Primary Outcome: Recurrence free interval
• Secondary Outcome: Primary complete response rate Pregnancy rate Side effect

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Female
• Exclude criteria: (1) The case with a history of the hypersensitivity that is serious for this study use medicine or the drug allergy (2)A history of the lactic acidosis (3)Patients on dialysis (4)Shock, failure heart, myocardial infarction, a cardiovascular injury including the pulmonary embolism (5)Excessive alcohol intake (6)Hepatic dysfunction (7) A history of the thrombosis (8)A case with the psychic disturbance that it seems that we need in the treatment or treatment with antimental medicine (9) Patients with diabetes (10)A case with the double cancer of the activity (11)In addition, the case that the chief physician judged to be inadequate.

Related Information

• Primary Sponsor: chiba university
• Source(s) of Monetary Support: none