healthy volunteers (hormonal birth control using combined oral contraception) MedDRA version: 19.0 Level: LLT Classification code 10073728 Term: Hormonal contraception System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Evaluna 30 30 Mikrogramm/150 Mikrogramm Filmtabletten
Product Name: EE30/LNG150 (Lisa)
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Concentr
Sponsors
Madaus GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Subject is informed, has been given ample time and opportunity to think about her participation and has given her written and personally dated informed consent obtained before undergoing any trial-specific procedure 2. Subject is a sexually active woman of child-bearing potential, at risk of pregnancy 3. Subject seeks contraception and agrees to use study COC as her primary birth control method 4. Subject is aged between 18 and 35 years at screening (inclusive) 5. Subject is able to communicate, participate, and comply with the requirements of the entire study 6. Subject is computer literate and able to complete the subject electronic diary 7. Subject has given her written specific consent to allow collection and use of contact details for managing alert call. 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 1623 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Venous thrombosis present or in personal or family history (e.g. deep venous thrombosis, pulmonary embolism) in any body region 2. Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris and transient ischaemic attack) in any body region 3. Cerebrovascular accident present or in history 4. The presence of at least one severe or multiple risk factor(s) for arterial thrombosis, including: • diabetes mellitus with vascular symptoms • severe dyslipoproteinemia (i.e. screening total serum cholestero=l 240 mg/dl and/or LDL cholesterol =160 mg/dl, as per APT III guidelines , or use of anti-hyperlipidemic agents) • valvular heart disease • atrial fibrillation 5. Known 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): such predisposing factors will not be specifically investigated, but patient personal and family history in this respect should be collected 6. History of other medical conditions associated with vascular AEs (e.g. haemolytic uremic syndrome, chronic inflammatory bowel disease such as Crohn’s disease or ulcerative colitis, sickle cell disease) 7. Hypertension defined as repeated measurements of systolic blood pressure >140 and diastolic blood pressure >90 mmHg 8. History of hereditary angioedema 9. History of migraine with focal neurological symptoms 10. Pancreatitis or a history thereof if associated with hypertriglyceridemia 11. Presence of hepatic disease (as per abnormal liver function at screening laboratory tests), or history thereof as long as liver function values have not returned to normal 12. History of being HIV or Hepatitis C positive 13. Presence or history of liver tumours (benign or malignant) 14. History of hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 15. Known or suspected sex-steroid influenced malignancies 16. Palpable breast tumours 17. Uterine fibroids 18. History of cervical cancer 19. HPV-positive at screening, PAP smear PAP III or higher 20. Known hypersensitivity to the active substances or to any of the excipients of Lisa coated tablets 21. BMI >30 kg/m² 22. Current smokers up to age 30 (inclusive) smoking more than 10 cigarettes/day 23. Subjects up to the age of 30 (inclusive) who consumed more than 10 cigarettes/day and either stopped smoking or reduced smoking to less than 10 cigarettes/day =24 months 24. Current smokers (or former smokers who stopped smoking = 24 months) aged more than 30 years 25. Desire to become pregnant during study period 26. Pregnancy or lactation period 27. Undiagnosed vaginal bleeding 28. Subjects who have had recent surgical or medical abortion, miscarriage or vaginal or cesarian delivery with less than three normal menstrual cycles prior to study enrolment 29. History of having used a contraceptive patch within 3 months prior to enrolment 30. History of having received injectable hormone contraceptives or other injectable hormones within the past 10 months prior to study enrolment 31. History of having a progestin-releasing intrauterine device in place over the 3 months prior to enrolment 32. Routine concomitant use of forms of contraception other than COCs with the exception of occasional condom use during t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is: • To demonstrate the contraceptive efficacy of the EE30/LNG150 84+7 extended-cycle regimen (provisional fantasy name: Lisa Lang) according to the requirements of the EMA “Guideline on clinical investigation of steroid contraceptives in women” (EMEA/CPMP/EWP/519/98 Rev 1).;Secondary Objective: 2.2 Secondary Objectives The “key secondary objective” of the study consists of the investigation of the superiority of the Lisa Lang extended-cycle regimen in comparison with the 21+7 conventional-cycle regimen (provisional fantasy name: Lisa Kurz) in reducing the total number of bleeding days over the study. Other secondary objectives of the study are: • To investigate and to compare the effect of the Lisa Lang extended-cycle regimen and the effect of the Lisa Kurz conventional-cycle regimen on bleeding patterns, cycle-associated complaints, acceptability of regimens. • To investigate general safety and tolerability of the Lisa Lang extended-cycle regimen and of the Lisa Kurz conventional-cycle regimen. • To follow-up the time to return of fertility up to one year in all subjects discontinuing oral contraceptive treatment, on cessation of the study medication, for wish of pregnancy.;Primary end point(s): Primary efficacy endpoint: • (unadjusted) Pearl Index ;Timepoint(s) of evaluation of this end point: After completion of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Main secondary efficacy endpoints: • Bleeding days • Bleeding pattern • Cycle-associated complaints • Safety ;Timepoint(s) of evaluation of this end point: After completion of the study. | — |
Countries
Germany
Contacts
Public ContactGroup Leader Study Manager
Meda Pharma GmbH & Co. KG
Outcome results
None listed