EUCTR2009-014911-11-CZ进行中（未招募）不适用
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
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
- 680
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
- •1.Signed and dated informed consent
- •2.Subjects aged between 18 and 35 years (inclusive).
- •3.Smokers with a maximum age of 30 years at time of informed consent.
- •4. Healthy female subjects requesting contraception and currently using a low-dose. EE containing 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.
- •5. 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]).
- •6. History of regular cyclic menstrual periods.
- •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
- •1. Known or suspected pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment).
- •2. 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.
- •3. Presence or history of prodromi 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 APC-resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
- •4. History of migraine with focal neurological symptoms.
- •5. Diabetes mellitus with vascular involvement.
- •6. Severe dyslipoproteinemia.
- •7. Obesity (Body Mass Index >32.0 kg/m2).
- •8. The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication (see under Special Warnings and Special Precautions for Use).
- •9. Moderate to severe hypertension (repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure >90 mmHg).
- •10. Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
- •11. Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
- •12. Jaundice and / or pruritus related to cholestasis (Gilbert´s syndrome excepted)
- •13. History of cholestatic jaundice associated with pregnancy or previous combined OC use.
- •14. Severe renal insufficiency or acute renal failure.
- •15. Presence or history of liver tumors (benign or malignant).
- •16. Systemic lupus erythematosus or a history of this condition.
- •17. Pemphigoid gestationis during a previous pregnancy.
- •18. Known or suspected sex-steroid influenced malignancies or premalignant disease (e.g. of the genital organs or the breasts).
- •19. Undiagnosed vaginal bleeding.
- •20. Uncontrolled thyroid disorder.
- •21. Chronic inflammatory bowel disease.
- •22. Hemolytic uremic syndrome.
- •23. Sickle cell anemia.
- •24. Porphyria.
- •25. Sydenham chorea.
- •26. History of herpes gestationis.
- •27. Otosclerosis-related hearing loss.
- •28. Epilepsy.
- •29. Clinically significant depression.
- •30. Hereditary angioedema.
- •31. Hypersensitivity to the active substances or to any of the excipients.
- •32. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
- •33. Abuse of alcohol, drugs, or medicines (e.g., laxatives).
- •34. Other contraceptive methods (sterilization, oral, vaginal, or transdermal hormonal
- •contraception during treatment, intrauterine devices (IUDs) with or without hormone
- •release, implants, long-acting preparations [e.g., depot-MPA, monthly contraceptive
- •injection] within a period of 3 times of the injection interval before start of treatment).
- •35. Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results.
- •36. Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator.
研究者
相似试验
进行中（未招募）
1 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 - Comparative trial in hormone withdrawal associated symptomsOral ContraceptionMedDRA version: 12.0Level: LLTClassification code 10030970Term: Oral contraceptionEUCTR2009-014911-11-GBBayer HealthCare AG
进行中（未招募）
不适用
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. - Comparative trial in hormone withdrawal associated symptomsOral contraceptionMedDRA version: 9.1Level: PTClassification code 10030970EUCTR2009-014911-11-ITBayer Healthcare AG680
进行中（未招募）
不适用
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 treatmentOral ContraceptionMedDRA version: 12.0Level: LLTClassification code 10030970Term: Oral contraceptionEUCTR2009-014911-11-PTBayer HealthCare AG680
进行中（未招募）
不适用
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 - Comparative trial in hormone withdrawal associated symptomsEUCTR2009-014911-11-DEBayer HealthCare AG680
进行中（未招募）
不适用
A Phase II Efficacy Study in Fistulizing Crohn's Disease PatientsTreatment of perianal fistulas in patients suffering from Crohn's Disease.MedDRA version: 14.0Level: PTClassification code 10016717Term: FistulaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 14.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2010-019973-13-DEovartis Pharma AG23