Oral Contraception MedDRA version: 14.0 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: YAZ
Product Name: YAZ
Product Code: BAY86-5300
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ethinylestradiol and Betadex
CAS Number: 256463-26-0
Current Sponsor code: ZK 2
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 680 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. 37. Major
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show superiority of 24/4 OC to 21/7 OC with regard to changes in frequency and intensity of hormone withdrawal associated symptoms on cycle days 22 – 28 from baseline to cycle 4 in approximately 550 women.;Secondary Objective: • to compare 24/4 OC to 21/7 OC (with regard to •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) •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) •change from baseline to cycle 4 in maximum intensity of individual hormone-withdrawal symptoms on cycle days 22 – 28, •composite scores per cycle during cycle days 1 – 24 and during cycle days 25 – 28 for 24/4 OC, •individual scores per cycle during cycle days 1 – 24 and during cycle days 25 – 28 for 24/4 OC, •composite scores per cycle during cycles days 1 – 21 and during cycle days 22 – 28 for 21/7 OC, •individual scores per cycle during cycles days 1 – 21 and during cycle days 22 – 28 for 21/7 OC •change from baseline to cycle 2 in the sum of composite score during cycle days 22 – 28 (AUC of days 22 - 28 for sum of 3 scores) ;Primary end point(s): The primary efficacy variable is the 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). | — |
Countries
Czech Republic, Germany, Italy, Portugal, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed