Comparative reference-controlled investigation of bleeding pattern under treatment with a vaginal delivery system (EVE112) containing a fixed dose combination of etonogestrel and ethinylestradiol – A multi-centre, multi-dose, open-label, parallel-group study in healthy females aged 18-40 years and at risk for becoming pregnant

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 670

Inclusion Criteria

1. sexually active, at risk for becoming pregnant and in a mutually monogamous relationship for at least 6 months at study entry
2. willing to rely on the IMPs as the primary method of contraception during study participation
3. age: = 18 years and = 40 years
4. body-mass index (BMI): = 18.5 kg/m² and = 32.0 kg/m²
5. good state of health
6. non-smoker, ex-smoker or moderate smoker (<10 cigarettes per day) for at least 3 months
7. known regular menstrual cycles from 21 to 35 days in length, with an intra-individual variation of ±3 days permitted within this range for at least 6 months
8. signed and dated informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in 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 670
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
2. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
3. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
4. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
5. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
6. presence of clinical relevant hypertension judged by investigator
7. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
8. having a partner who is known to be HIV-positive
9. 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 accident, inborn or acquired predisposition for venous or arterial thrombosis such as APC resistance, antithrombin-III-deficiency, protein-C or –S-deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant, known Leiden factor V mutation
10. plans for surgery requiring prolonged immobilization
11. any presence or history of malignancies, personal history of benign breast diseases, family history of breast cancer
12. abnormal PAP smear at screening examination
13. severe dyslipoproteinaemia (LDL > 130 mg/dl and HDL < 35 mg/dl or LDL/HDL ratio > 5)
14. diabetes mellitus with end-organ involvement or >20 years’ duration
15. history or signs of migraine with focal neurological symptoms
16. history of ectopic pregnancies
17. existing cervicitis or bleeding cervical erosions
18. abnormal uterine bleeding of unknown origin within past 6 months
19. amenorrhea with unknown cause within past 6 months
20. prolapse of uterine cervix, cystocele and/or rectocele
21. severe or chronic constipation
22. sterilized partner
Lack of suitability for the clinical trial
23. acute or chronic diseases which may interfere with the aims of the clinical trial
24. history of or current drug or alcohol dependence
25. participation in a clinical trial during the last 2 months prior to individual enrolment of the subject
26. repeated intake of any medication during the last 2 weeks prior to individual start of treatment cycle of the subject which might interfere with absorption, efficacy or safety of the IMPs
27. repeated intake of food or beverages containing St. John's Wort after screening examination and prior to randomisation
28. use of vitamin K within two weeks prior to individual start of treatment cycle of the subject and regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) by the subject
29. regular use of anticoagulants or inhibitors of platelet aggregation within 1 month prior to individual start of treatment cycle of the subject
30. use of any intramuscularly administered sexual hormone preparations within 2 months (intramuscularly administered depot preparations used once per month) or 6 months (intramuscularly administered depot preparations used once per 3 months) as well as hormonal intrauterine system

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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