CTRI/2010/091/001229已完成4 期
Safety Assessment of Oral Contraceptive pill containing Drospirenone & Ethinyl estradiol on Quality of life.
Glenmark Pharmaceutical Ltd0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Married females with age >18 to 40 yrs
- •Healthy women with history of normal menses or cycles [mean cycle duration of 28+/-5 days]
- •Women willing to give written Informed Consent & willing to come for follow up
排除标准
- •Hypersensitivity / contraindication to Drospirenone or any ingredients of the oral contraceptive pill
- •Pregnant and lactating women or with unexplained vaginal bleeding.
- •BMI >25 or with history of metabolic or endocrine disorders
- •History of psychoactive disease or on antidepressants
- •Aspartate aminotransferase (AST) and/or alanine -aminotransferase (ALT) 2.5 x ULN or lower
- •Serum creatinine 1.5 x ULN
- •Any condition likely to hamper compliance of the patient with the study protocol
- •Participated in a new drug study in past 3 months
- •Women with hypertension, hypercholesterolemia, diabetes
- •Women with history of smoking, myocardial infarction, stroke, peripheral vascular disease, or clotting disorders
- •Women on oral anticoagulants or prolonged use of high doses of NSAIDs
研究者
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