EUCTR2005-002125-32-DE进行中（未招募）不适用
A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a 1-year safety extension
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •General inclusion criteria
- •- Signed and dated informed consent
- •- Healthy volunteer requesting contraception
- •- Age between 18 and 35 years (inclusive), smokers maximum age of 30 years
- •(inclusive) at screening
- •- Non-suspicious (normal) cervical smear taken at visit 1 or within the last 6 months
- •prior to visit 1 (provided a corresponding report is available)
- •Additional inclusion criteria subgroups
- •- Mean ‘pretreatment’ BMD T-score > -1 at the lumbar spine (L1-L4) (for subgroup
- •1 ‘bone mineral density’)
- •- Wash-out period of 2 months if sex hormones were used prior to start of study
- •medication (for subgroup 1 and 2 ‘metabolic parameters, hormones, biopsies’)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •General and gynecological exclusion criteria
- •- Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or
- •lactation before start of treatment)
- •- Body mass index (BMI) < 18 and > 30
- •- Hypersensitivity to any of the study drug ingredients
- •- Any disease or condition that can compromise the function of the body systems
- •and could result in altered absorption, excessive accumulation, impaired
- •metabolism, or altered excretion of the study medication
- •- Any disease that may worsen under hormonal treatment or might interfere with
- •the conduct of the study or the interpretation of the results (e.g., herpes
- •gestationis or idiopathic icterus during a previous pregnancy; middle-ear deafness
- •(otosclerosis), Sydenham chorea, porphyria, disturbances in bile flow (presence or
- •history of cholestasis, gallstones), systemic lupus erythematodes)
- •- Diagnosed or suspected malignant or premalignant disease
- •- Liver diseases: presence or history of severe hepatic diseases including benign or
- •malignant tumors. There should be an interval of at least 3 months between the
- •start of study medication intake and the return of liver function values to normal.
- •- Vascular diseases and coagulation disorders: Presence or history of venous
- •thromboembolic diseases (deep vein thrombosis, pulmonary embolism), presence
- •or history of arterial thromboembolic diseases (e.g., myocardial infarction, stroke),
- •and any condition which could increase the risk to suffer from any of the above
- •mentioned disorders, e.g., a positive family history (event that occurred in a
- •sibling or a parent at an early age) or a suspected hereditary predisposition.
- •- Other diseases: chronic inflammatory bowel disease (Crohn's disease or
- •ulcerative colitis), hemolytic uremic syndrome, migraine with focal neurologic
- •symptoms (complicated migraine)
- •- Undiagnosed vaginal bleeding
- •- Uncontrolled thyroid disorders
- •- Dyslipoproteinaemia
- •- Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia
- •(fasting triglycerides = 200mg/dl; fasting total cholesterol = 260mg/dl)
- •- Uncontrolled arterial hypertension (confirmed systolic blood pressure > 140 mmHg
- •or confirmed diastolic blood pressure > 90 mmHg)
- •- Diabetes mellitus with vascular involvement
- •- Sickle-cell anemia
- •- Current or history of clinically significant depression
- •- Current or history of alcohol or drug abuse
- •- Prohibited concomitant medication (as listed in protocol)
- •- Laboratory test results with clinically relevant abnormalities
- •- Intake of an experimental drug within 1 month prior to inclusion in the study (visit
- •- Other contraceptive methods such as sterilization or use of intrauterine devices
- •- Less than six cycles following i.m. depot contraception, less than one cycle
- •following the removal of hormone-containing implants or intrauterine devices with
- •or without hormone release (visit 2)
- •- Volunteers who previously discontinued the use of oral contraceptives due to
- •intracyclic bleeding episodes
- •- Volunteer is a dependant person, e.g., a relative / family member, a member of
- •the investigator’s staff, and / or is a student of the investigational site
- •Additional exclusion criteria for subgroup 1 ’bone mineral density‘
- •- BMI < 20 and > 30
- 另有 2 项未显示
研究者
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