Investigation of ovulation inhibition, effects on metabolic parameters and haemostatic system for indication of contraception MedDRA version: 14.1 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: BONADEA PLUS, film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Zentiva k.s. Prague
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.female 2.age: 18 – 35 years inclusive; questioned at screening examination 3.body-mass index (BMI): =30.0 kg/m²; determined at screening examination 4.good state of health 5.both ovaries visible upon transvaginal ultrasonography; observed at screening examination 6.ovulation observed by TVUS on or before day 27 (±1) of the pre-treatment cycle 7.progesterone blood concentration =16 nmol/L within 5 days after ovulation has been observed during pre-treatment cycle 8.non-smoker, ex-smoker for at least 6 months or moderate smoker (10 cigarettes or 2 cigars or 2 pipes per day) aged =30 years; questioned at screening examination 9.written informed consent, after having been informed about benefits and potential risks of the clinical trial 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.existing diseases or pathological findings of uterus and/or ovaries which might interfere with the efficacy, safety or tolerability of the IMPs 2.existing cardiac or haematological diseases or related pathological findings which might interfere with the efficacy, safety or tolerability of the IMPs 3.existing hepatic and/or renal diseases or related pathological findings which might interfere with the efficacy, safety or tolerability of the IMPs 4.existing gastrointestinal diseases or related pathological findings which might interfere with the absorption, efficacy, safety or tolerability of the IMPs 5.history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders 6.known allergic reactions or intolerances to the active ingredients used or to constituents of the pharmaceutical preparations 7.subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator 8.severe and/or uncontrolled hypertension 9.systolic blood pressure >140mmHg 10.diastolic blood pressure >90mmHg 11.heart rate >100bpm 12.laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator 13.presence or history of venous or arterial thrombosis (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or prodromal conditions (e.g. angina pectoris, transient ischaemic attack)), cerebrovascular insult, hereditary or acquired predisposition for venous or arterial thrombosis 14.anamnestic signs for increased risk of thrombotic events in family history 15.hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin-antibodies, lupus anticoagulant) 16.presence or history of tumours (benign or malignant) of liver and pituitary 17.known or suspected sex-hormone influenced malignancies, e.g. of genital organs or breasts 18.abnormal PAP smear (>PAP II) at screening examination or documentation of abnormal smear performed within 2 years prior to screening examination 19.severe dyslipoproteinaemia 20.Diabetes mellitus 21.unclarified vaginal bleeding 22.amenorrhea with unkown cause 23.history or signs of migraine with focal neurological symptoms 24.any acute or chronic disease, disorder and/or abnormality which may interfere with the aims of the clinical trial 25.history of or current drug or alcohol dependence 26.regular intake of alcoholic beverages of >2 units per day 27.blood donation or other blood loss of more than 400ml within the last 2 months prior to individual start of pre-treatment cycle of the subject 28.use of any investigational drug during the last 2 months prior to individual start of pre-treatment cycle of the subject 29.repeated intake of any systemically available medication during the last 2 months prior to start of pre-treatment cycle which might interfere with absorption, pharmacodynamics or safety of the IMPs 30.repeated intake of medication during the last 2 months prior to start of the pre-treatment cycle which is known to interfere with gastrointestinal and/or hepatic enzymes (e.g. phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, nevirapin, griseofulvin, ketoconazole, herbal remedies containing Hyperi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aims of this clinical trial are: • descriptive characterisation of the influence of Test or Reference on ovarian activity determined by means of maximum follicular diameter and Hoogland score • descriptive characterisation of the effect of Test or Reference on endometrial thickness, cervical mucus as well as on the pituitary and ovarian hormones the latter determined via follicle stimulating hormone (FSH), luteinising hormone (LH), estradiol (E2) and progesterone (P) • descriptive characterisation of effect of Test or Reference on sex hormone binding globulin (SHBG) and corticosteroid binding globulin (CBG) levels, C-reactive protein, lipid profile as well as haemostatic and carbohydrate parameters • descriptive characterisation of bleeding pattern • descriptive characterisation of return of ovulation • descriptive characterisation of overall safety and tolerability in the study population;Secondary Objective: No secondary objectives have been defined.;Primary end point(s): Efficacy Parameters: • ovarian activity (maximum follicular diameter, Hoogland score);Timepoint(s) of evaluation of this end point: End points will be evaluated at the end of the study after data base lock. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Parameters: •endometrial thickness •cervical mucus (Insler score) •pituitary and ovarian hormones Safety parameters: •SHBG and CBG levels •lipid profile and CRP •haemostatic parameters •carbohydrate parameters •bleeding pattern •return of ovulation;Timepoint(s) of evaluation of this end point: End points will be evaluated at the end of the study after data base lock. | — |
Countries
Netherlands
Outcome results
None listed