EUCTR2011-002602-78-DE进行中（未招募）不适用
A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of DR-102 Compared to a 28-day Standard Oral Contraceptive Regimen, on Hemostatic Parameters in Healthy Women
Teva Women's Health Research&Development, a division of Teva Branded Pharmaceutical Products R&D, Inc.0 个研究点目标入组 240 人开始时间: 2011年7月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •I.1 Female subjects 18-40 years of age, inclusive, at the time of consent;
- •I.2 Premenopausal, non-pregnant, not breast-feeding for a period of 2months prior to the Screening Visit
- •I.3 Body Mass Index (BMI) = 18 kg/m2 and < or equal 30 kg/m2;
- •I.4 One spontaneous menstrual cycle (that occurs approximately 23-35 days after previous menses or withdrawal bleeding episode)prior to or concurrent with the Screening Period
- •I.5 Willing to be randomized to one of two open-label oral contraceptive treatment regimens and willing to adhere to the randomized treatment regimen for the 6-month study period;
- •I.6 Not at risk for pregnancy or willing and able to use an effective method of nonhormonal contraception (non-hormone releasing IUD, diaphragm, spermicidal foam, contraceptive sponge, condoms) from the time of signed informed consent through last dose of IMP;
- •I.7 Able to complete all study procedures; capable of and willing to be present at the study site for all study visits; and
- •I.8 Able and willing to read, understand and sign an informed consent after the nature of the study has been fully explained.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •E.1 Any condition (history or presence of) which contraindicates the use of combination oral contraceptives:
- •thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders;
- •migraine headaches with focal, neurological symptoms; cerebrovascular or coronary artery disease or myocardial infarction; diabetes mellitus;
- •chronic renal disease; uncontrolled or untreated hypertension; cholestatic jaundice; major surgery with prolonged immobilization;
- •carcinoma of the breast; endometrial carcinoma or estrogen dependent neoplasia; undiagnosed abnormal genital bleeding;
- •impaired liver function or disease; hepatic adenomas or carcinomas;
- •E.2 Concomitant use of sex hormones
- •E.3 Any history of, or current deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease;
- •E.4 Venous thromboembolic event in a parent or sibling subject.
- •E.5 Acute or chronic severe liver dysfunction or disease.
- •E.6 Within 2 months postpartum or post-abortion at the Screening Visit;
- •E.7 Smoker and age = 35 years
- •E.8 History of a previous clinically significant adverse event while taking hormonal contraceptives that contraindicates the use of hormonal contraceptives;
- •E.9 History of having received injectable hormone therapy
- •or has a contraceptive implant in place
- •E.10 Use of any medication, which could significantly interfere with study assessments or with the efficacy of oral contraceptives
- •E.11 Known hypersensitivity or previous intolerance to estrogens and/or progestins;
- •E.12 Any clinically significant Pap result that would necessitate further evaluation by biopsy;
- •E.13 History of noncompliance with taking medication(s);
- •E.14 Known or suspected alcohol or drug abuse
- •E.15 Use of any experimental drug or device
- •E.16 Known human immunodeficiency virus (HIV) and/or Hepatitis C positive status;
- •E.17 Any employee or relative of an employee of the Sponsor, any Investigator Site employee or relative of employees working on the study;
- •E.18 Any abnormal finding or condition deemed clinically significant by the Investigator or Sponsor that contraindicates the use of oral contraceptives; or
- •E.19 Any condition or finding the Investigator or Sponsor believes would interfere with the subject’s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at risk
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