Contraception
Conditions
Interventions
Product Name: N/A
Product Code: GRT4248
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ethinylestradiol
CAS Number: 57-63-6
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Grünenthal GmbH
Laboratorios Andrómaco S.A. (Co-sponsor Spanien)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy, sexual active women of child-bearing potential aged 18 – 40 years (non smoker) or 18 – 35 years (smoker) on admission; women using nicotine replacement are considered smokers • Last three cycles before admission were regular (i.e. cycle length between 24 and 35 days) • Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator • Negative pregnancy test • Wish for contraception for 6 cycles • BMI = 30 • Written informed consent given 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: • Participation in another study of investigational medicinal products or devices parallel to, or less than 30 days before the admission visit, or previous participation in this study • Known to or suspected of not being able to comply with the study protocol and the use of the investigational medicinal products • Pregnancy • Breast feeding mother • Evidence or history of alcohol, medication or drug dependency • Evidence or history of neurotic personality, psychiatric illness, epilepsy or suicide risk • Hypersensitivity to any of the ingredients of the investigational products • Any chronic disease (e.g. hepatic and/or renal) or diet that might affect drug absorption, metabolism or excretion • Planned surgery requiring withdrawal of an oral contraceptive during the anticipated time or participation in this study • Pap III - V in a cytological smear • Unexplained amenorrhoea or genital bleeding • Known polycystic ovary syndrome, anovulatory cycles, hysterectomy, bilateral oophorectomy • Concomitant use of other hormonal contraceptives including implants, depot contraceptives, patches, vaginal ring • Concomitant estrogen or progesterone containing medication • Concomitant use of an IUD • Migraine accompanied by sensation, perception and/or motor symptoms (migraine accompagnée) • Need for concomitant treatment (longer than 5 days) with - 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 (specifications see protocol) • Pancreatitis • Circulation affecting and metabolic diseases (specifications see protocol) • Tumours: presence, history or suspicion of any malignant and hormone sensitive tumours, e.g. androgen producing tumours, ovarian cancer, adrenal tumours, melanoma, breast or uterus • Other diseases - Porphyria (all three forms, in particular acquired porphyria) - Motor disorders (particularly paresis) - Severe epigastric pain, enlargement of the liver, or symptoms of intraabdominal haemorrhage - Otosclerosis deteriorating in previous pregnancies - Known endometrial hyperplasia - Known sexual transmitted disease, e.g. Chlamydia infection, HIV, gonorrhoea - Acute sensory disorders, e.g. visual or hearing disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the safety of 0.02 mg ethinylestradiol / 2 mg chlormadinone acetate, given for 24 days each 28 days cycle in comparison to 0.02 mg ethinylestradiol / 0.15 mg desogestrel given for 21 days each 28 days cycle;Secondary Objective: N/A;Primary end point(s): Since there is no single criterion of outstanding importance for the safety evaluation several endpoints will be evaluated: • adverse events • cycle control • effect on body weight • dysmenorrhoea | — |
Countries
Germany, Italy, Spain
Outcome results
None listed