NCT01557023撤回3 期
Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol
Eurofarma Laboratorios S.A.1 个研究点 分布在 1 个国家开始时间: 2013年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment
研究概览
简要总结
This trial will study the percentage of women with at least one occurrence of intracyclic bleeding (bleeding and/or spotting) during the cycles 2 and 3 of treatment with test or reference drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sign, initial and date the informed consent form;
- •Female patients, with child bearing potential, aged 18 to 35 years;
- •Have indication to receive progesterone and estrogen-based low oral hormone treatment for at least 7 cycles (approximately 7 months) for birth control;
- •Be able to comply with the study protocol;
- •Show normal result in cervical-vaginal cytology conducted up to 3 months before study enrollment or be willing to repeat the screening visit test, which result must also be normal;
- •Be willing to use one of the study drugs
排除标准
- •Is pregnant or breastfeeding, suspecting to be or planning to get pregnant;
- •Patients currently using oral contraceptives with drospirenone 3 mg/ ethynilestradiol 30 mcg or dianogest 2 mg/ ethynilestradiol 30 mcg.
- •Have history of gynecologic surgery such as hysterectomy, total oophorectomy or tubal ligation;
- •Smoke over 10 cigarettes a day;
- •Have any severe comorbidities (at the investigator's criteria), including bowel inflammatory disease
- •Have hypertension, showing at least one of the following conditions:
- •Systolic pressure >140 mm Hg or diastolic pressure >90 mm Hg in sitting position;
- •Current use of pharmacological treatment for hypertension;
- •Show history or currently have venous or arterial thromboembolism;
- •History of breast or genital cancer;
- •Have obesity (BMI >30 kg/m2);
- •Have liver disease or changed lab values;
- •Currently have dysplasia or malignancy in cervical-vaginal cytology;
- •Concomitantly use CYP3A4 metabolizing drugs or drugs causing drug interaction with other study drugs;
- •History of abortion one (1) month before study enrollment;
- •History of childbirth or breastfeeding 3 months before study enrollment;
- •Have hypersensitivity to any of the study drug components;
- •Patients with long-term disability, who have undergone a major surgery or any surgery in legs or major traumatism in the last 6 months;
- •Have current diagnosis of sexually transmitted disease;
- •Have used injectable hormones 3 months before study enrollment;
- •Have used hormone implant 6 months before study enrollment;
- •Have participated in another clinical trial in the last 12 months.
研究组 & 干预措施
dienogest 2 mg/ethynilestradiol 30 mcg;
Experimental
干预措施: barrier methods (Drug)
Yasmin®
Active Comparator
干预措施: barrier methods (Drug)
结局指标
主要结局
Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment
时间窗: 2 and 3 cycles (each cycle is 21 days)
次要结局
- Percentage of women with intracyclic bleeding during treatment cycles 2 to 7(2 and 7 cycles (each cycle is 21 days))
研究者
研究点 (1)
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