NCT02617537撤回3 期
A Multinational, Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study to Investigate the Efficacy and Safety of the Oral Hormonal Contraceptive BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) Over 16 Weeks for the Treatment of Women With Dysmenorrhea
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
- Bayer
- 主要终点
- Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6
研究概览
简要总结
The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit 1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during the menstrual period of the screening period
- •Good general health (except for findings related to dysmenorrhea) as proven by medical history
- •Patients aged 18 years or older at the time of obtaining informed consent; smokers must not be older than 35 years at the time point of informed consent
- •Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains (HPV 16, HPV18).
- •Women of childbearing potential must agree that adequate contraception will be used when they are sexually active. This applies from signing of the informed consent form until 2 weeks after the last study drug administration.
排除标准
- •Pregnancy (confirmed or suspected) or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
- •Patients who wish to become pregnant during the course of the study
- •Body Mass Index (BMI) > 32 kg/m2
- •Hypersensitivity to any ingredient of the study drug
- •Laboratory values outside inclusion range before randomization
- •Any diseases or conditions 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 diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
研究组 & 干预措施
BAY86-5300
Experimental
Patients suffering from dysmenorrhea, treated with Yaz
干预措施: EE20/DRSP(YAZ,BAY86-5300) (Drug)
Placebo
Placebo Comparator
Patients suffering from dysmenorrhea,treated with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6
时间窗: Baseline to week 17
The patient marks the individual pain impression on a visual analogue scale in the range 0 (no pain) to 100mm (worst pain ever experienced)
次要结局
- Number of days with dysmenorrhea(Up to 16 weeks)
- Changes from baseline to each menstrual period of total number of taken supportive analgesic medication(Baseline to week 16)
- Number of participants with adverse events as measure of safety and tolerability(Up to 16 weeks)
- Changes from baseline to each menstrual period of severity of lumbago(Up to 16 weeks)
- Change in dysmenorrhea score(Baseline to week 16)
- Clinical Global Impression(CGI)(At week 16)
- Self administered SF-36 questionnaire(At baseline and week 17)
- Changes from baseline to each menstrual period of severity of headache(Up to 16 weeks)
- Changes from baseline to each menstrual period of days without supportive analgesic medication.(Baseline to week 16)
- Changes from baseline to each menstrual period of severity of nausea/vomiting(Up to 16 weeks)
研究者
相似试验
已完成
2 期
Use of an Oral Beta-2 Agonist in Persons With Spinal Cord InjurySpinal Cord InjuryNCT00755079US Department of Veterans Affairs40
已完成
3 期
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular RiskAtherosclerotic Cardiovascular DiseaseHypercholesterolemiaNCT02991118Esperion Therapeutics, Inc.779
已完成
3 期
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)Atherosclerotic Cardiovascular DiseasesHypercholesterolemiaNCT02666664Esperion Therapeutics, Inc.2,230
已完成
3 期
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or PlaceboCardiovascular DiseasesStatin Adverse ReactionNCT02993406Esperion Therapeutics, Inc.13,970
撤回
2 期
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer PatientsLiver FibrosisHEPATITIS B CHRONICHepatocellular CarcinomaNCT02289300A2 Healthcare Taiwan Corporation