A Multicentre, Prospective, Open-label, Non-comparative Study (NCT06067256) | Clinical Trial Compass
UnknownPhase 4
A Multicentre, Prospective, Open-label, Non-comparative Study
Italy228 participantsStarted 2023-07-20
Plain-language summary
As there are no recent studies conducted in Italy on the profile of this COC, the purpose of this study is to evaluate its efficacy and tolerability in a given subset of women residing in Italy that are in need of contraception. Evaluate the cycle control: breakthrough bleeding (bleeding and/or spotting between cyclically regular onset of menses) of monophasic oral contraceptive pill Effimia® (NGM250 + EE35) in a population of women residing in Italy.
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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Inclusion Criteria:
* All the following criteria must be met.
* Healthy women aged between 18 and 35 years (inclusive) in need of contraception.
* Subjects residing in Italy and having a good knowledge of the Italian language, such as to correctly understand the Informed Consent Form, the instructions for use, and to ensure potential adhesion to the study.
* Subjects providing written Informed Consent Form.
* Subjects willing to comply with the study protocol.
Exclusion Criteria:
* Subjects who meet even one of the following criteria will be excluded from the study.
* Subjects presenting any contraindications to the use of Combined Oral Contraceptives (COC) according to the current Summary of Product Characteristics (SmPC) of Effimia®, i.e. subjects presenting (or have ever presented) myocardial infarction, transient ischemic attack (TIA), stroke, angina pectoris, deep vein thrombosis (DVT), pulmonary embolism (PE) (or presence of blood clot in other organs than legs and lungs), any blood clotting disorder (such as protein C deficiency, protein S deficiency, antithrombin-III deficiency), or subjects that need to undergo surgery or that have to lie down for a long period of time (including the risk of previous deep vein thrombosis (DVT), arterial thromboembolism (ATE), hypertension in course of treatment and diabetes). If any of the listed conditions should appear during the use of the tested COC, the product must be stopped immediately, and the subject withdraw…