Wish for contraception
Conditions
Interventions
Trade Name: Belara
Product Name: Belara
Product Code: CG5025
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ethinylestradiol
CAS Number: 57-63-7
Concentration unit: mg milligram(s)
Conce
Sponsors
Grünenthal GmbH
Laboratorios Andrómaco S.A. (co-sponsor Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy, sexual active woman of child-bearing potential aged 18 - 40 years (non smoker) or 18 - 35 years (smoker) at admission - Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator - Wish for oral contraception for at least 392 days - BMI = 30 - HEMOSTATIC/METABOLIC SUBGROUP: - Healthy, non-smoking, sexual active woman of child-bearing potential aged 18 - 40 years at admission - Wish for oral contraception for at least 392 days followed by approximately 2 months with a barrier method, e.g. condoms 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
Exclusion criteria
Exclusion criteria: General criteria - Pregnancy - Breast feeding - Evidence or history of alcohol, medication or drug dependency - Severe psychiatric illness, epilepsy or suicide risk - Any chronic disease (e.g. hepatic and/or renal) or diet that might affect drug absorption, metabolism or excretion Study specific - Planned surgery requiring withdrawal of an oral contraceptive during the anticipated time of participation in this study - Cytologic evidence of intraepithelial neoplasia in a cervical smear (e.g. Pap smear grade III to V) - Unexplained amenorrhea or genital bleeding -Known polycystic ovary syndrome, anovulatory cycles, hysterectomy, bilateral oophorectomy - Administration of any other hormonal contraceptives including patches and vaginal rings during the medication cycles - Use of intra-uterine devices (IUD) with or without hormone impregnation during the medication cycles - Use of implantable contraceptives during the medication cycles - Use of injectable contraceptives within the preceding 6 months (date of injection) before admission and during the medication cycles - Use of estrogen or progesterone containing medication during the medication cycles - Regular concomitant use of a barrier method - Migraine with focal neurological symptoms (migraine accompagnée) - Need for concomitant treatment (longer than 5 days) with • medicines that increase gastrointestinal motility (e.g. metoclopramide) or impair absorption (e.g. activated charcoal) • active substances inducing microsomal enzymes in the liver such as rifampicin, rifabutin, barbiturates, anti-epileptics (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone, barbexaclone), griseofulvin, modafinil, protease inhibitors (e.g. ritonavir), or St. John’s Wort • antibiotics - Hepatic diseases - Circulation affecting and metabolic diseases - Pancreatitis or history of such a condition, if associated with severe hypertriglyceridemia - Tumors: presence, history or suspicion of any malignant or hormone-sensitive tumor - Other diseases: • Porphyria (in particular acquired hepatic porphyria) • Otosclerosis deteriorating in previous pregnancies • Acute sensory disorders, e.g. visual or hearing disorders • Motor disorders, particularly paresis • Severe epigastric pain, enlargement of the liver, or symptoms of intraabdominal hemorrhage Study specific for volunteers in hemostatic/metabolic subgroup - Use of oral contraceptives, contraceptive vaginal rings, or contraceptive patches within 1 cycle before the pre-medication cycle - Concomitant and prior use of intra-uterine devices (IUD) with or without hormone impregnation within 1 cycle before the pre-medication cycle - Use of implantable contraceptives within the preceding 2 cycles before the pre-medication cycle - Parturition, miscarriage, or abortion within the preceding 3 months before the baseline visit - Concomitant use of anticoagulants, i.e. heparins and coumarins - Concomitant medications affecting the lipoprotein and/or carbohydrate metabolism (e.g. systemic glucocorticoides, ß-blockers, thiazide diuretics, antilipemic agents) - Concomitant diseases affecting the lipoprotein and/or carbohydrate metabolism (e.g. diabetes mellitus, hypothyroidism, cholestasis, nephrotic syndrome, renal insufficiency requiring hemodialysis) - Fasting total cholesterol > 6.47 mmol/l (> 250 mg/dl) and/or triglycerides > upper limit of normal at baseline - Concomitant use of platelet aggregation inhibitors and/or non-steroidal anti-i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: not applicable;Primary end point(s): - number of days with intermenstrual bleeding related to the number of potential days with intermenstrual bleeding during 392 days, - total number of days with bleeding during 392 days and within each of 4 reference periods of 98 days, - intensity of bleeding ;Main Objective: The objective of this study is to show that the safety and efficacy of an extended oral contraceptive treatment with Belara/CG5025 taken for two 196-days cycles (189 days with active pill intake plus 7 days pill-free interval) is comparable with the safety and efficacy of the conventional treatment, i.e. Belara/CG5025 taken for fourteen 28-days cycles (21 days with active pill intake plus 7 days pill-free interval), where in the EC group the mean number of days with intermenstrual bleeding related to the number of potential days with intermenstrual bleeding does not exceed 16.0% during two ECs. | — |
Countries
Hungary, Spain
Outcome results
None listed