NCT01076582已完成3 期
A Multi-centre, Randomized, Double-blind, Active Control, Parallel-group, 2-arm Study to Investigate the Effect of Ethinylestradiol / Drospirenone (0.02 mg/3 mg) Oral Contraception in a 24/4 Regimen Compared to Ethinylestradiol / Desogestrel (0.02 mg/0.15 mg) Oral Contraception in a 21/7 Regimen on Hormone Withdrawal Associated Symptoms in Otherwise Healthy Women After 4 Cycles of Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 592
- 主要终点
- Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales).
研究概览
简要总结
This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 and 35 years (inclusive)
- •Smokers with a maximum age of 30 years at time of informed consent
- •Healthy female subjects requesting contraception and currently using a low-dose EE containing oral contraceptives (OC) in a 21-day regimen (for at least three months) and suffering from at least two of the hormone withdrawal associated symptoms headache, pelvic pain and bloating during all three months prior the planned baseline cycle and requiring further OC use
- •To be valid for randomization, the total 7-day composite score of hormone-withdrawal symptoms during the baseline cycle must show an increase of at least 50% during Day 22 - 28 versus the 21-day composite score during Day 1 - 21 (21-day score divided by three [for normalization])
- •History of regular cyclic menstrual periods
排除标准
- •Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, or presence or history of prodrome of a thrombosis (e.g. transient ischemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APCresistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
- •History of migraine with focal neurological symptoms.
- •Diabetes mellitus with vascular involvement.
- •Obesity (Body Mass Index >32.0 kg/m2)
- •Moderate to severe hypertension (repeated measurements of systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg).
- •Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
- •Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
- •Jaundice and / or pruritus related to cholestasis (Gilbert´s syndrome excepted), or history of cholestatic jaundice associated with pregnancy or previous combined OC use
- •Severe renal insufficiency or acute renal failure.
- •Presence or history of liver tumors (benign or malignant), or known or suspected sex-steroid influenced malignancies or premalignant disease (e.g. of the genital organs or the breasts).
研究组 & 干预措施
Arm 1
Experimental
干预措施: EE20/DRSP (YAZ, BAY86-5300) (Drug)
Arm 2
Active Comparator
干预措施: Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon) (Drug)
结局指标
主要结局
Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales).
时间窗: Cycle days 22 - 28 of baseline cycle and cycle 4.
次要结局
- heart rate(up to 10 days after end of cycle 4)
- rescue medication consumption(baseline cycle and cycle 4)
- bleeding pattern(reference period is 90 days.)
- Adverse Event collection(up to 10 days after end of cycle 4)
- change from baseline to cycle 4 in number of days, where individual hormone withdrawal symptoms are present on cycle days 22 - 28 (i.e. Likert Scale >= 1),(Cycle days 22 - 28 of baseline cycle and cycle 4)
- change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28,(Cycle days 22 - 28 of baseline cycle and cycle 4)
- change from baseline to cycle 4 in the sum of individual scores during cycle days 22 - 28 (AUC of days 22 - 28 for each score),(Cycle days 22 - 28 of baseline cycle and cycle 4)
- evaluation of questionnaires: Q-LES-Q (short version)(baseline cycle and cycle 4)
- blood pressure(up to 10 days after end of cycle 4)
研究者
相似试验
已完成
2 期
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine HeadachesMigraineNCT00781456Duramed Research109
已完成
3 期
Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and HeadacheOral ContraceptiveHeadachePelvic PainNCT00778609Bayer449
已完成
3 期
Effects of SH T00658ID on LibidoContraceptionLibidoNCT00764881Bayer217
已完成
3 期
Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne PapulopustulosaAcne VulgarisNCT00280657Bayer1,326
撤回
3 期
Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)ContraceptionNCT01723579Organon and Co