Safety, efficacy and tolerability investigations of a hormonal contraceptive in healthy females aged 18-40 years. MedDRA version: 19.0 Level: LLT Classification code 10073728 Term: Hormonal contraception System Organ Class: 100000004865
Conditions
Interventions
Product Name: EVE112
Pharmaceutical Form: Vaginal delivery system
INN or Proposed INN: ETHINYLESTRADIOL
Current Sponsor code: EE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Evestra GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - descriptive comparison of the effect of Test and Reference on bleeding pattern over 6 cycles of treatment - assessment of pregnancy rates under treatment with Test and Reference over 6 cycles of treatment - descriptive comparison of the effect of Test and Reference on haemostasis parameters over 6 cycles of treatment - descriptive characterisation of the safety (including local tolerability) of Test and Reference over 6 cycles of treatment ;Secondary Objective: - descriptive characterisation of the safety (including local tolerability) of Test and Reference over a total of 13 cycles of treatment (including 7 cycles of safety follow-up);Primary end point(s): bleeding pattern assessment of pregnancy rates haemostasis parameter (prothrombin fragment 1+2, APC resistance (ETP-based), APC resistance (APTT-based), d-dimer, factor VII, factor VIII, factor II, antithrombin, protein S activity, protein C activity, SHBG) safety (including local tolerability);Timepoint(s) of evaluation of this end point: bleeding pattern, pregnancy rates, haemostasis after 6 cycles safety (AEs, local tolerability) after 6 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): safety (AEs, local tolerability) ;Timepoint(s) of evaluation of this end point: safety (AEs, local tolerability) after 13 cycles | — |
Countries
Bulgaria, Moldova, Republic of, Poland, Russian Federation
Contacts
Public ContactClinical Trials
SocraTec GmbH
Outcome results
None listed