Characterisation of ovulation inhibition and effects on parameters of the human body of multiple doses of a fixed-dose combination product containing 0.02 mg ethinylestradiol and 2 mg dienogest (hormons) in comparison to a marketed product containing 0.02 mg ethinylestradiol and 0.10 mg levonorgestrel in healthy females of childbearing potential

• Conditions: Investigation of ovulation inhibition, effects on metabolic parameters and haemostatic system for indication of contraception; MedDRA version: 14.1Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2012-000041-12-NL
• Lead Sponsor: Zentiva k.s. Prague

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-15
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified