This clinical trial is focused on studying the effects of a hormonal contraceptive treatment for women. The treatment being tested is a monophasic oral contraceptive pill called Effimia, which contains two active substances: norgestimate and ethinylestradiol. These substances are commonly used in birth control pills to prevent pregnancy. The study aims to evaluate how well this contraceptive controls the menstrual cycle, specifically looking at any unexpected bleeding or spotting that may occur between regular menstrual periods.
The purpose of the study is to understand the pattern of menstrual bleeding, how well the treatment is tolerated, and how consistently it is used by participants. Women participating in the study will take the contraceptive pill for a period of six months. During this time, researchers will monitor various aspects of their menstrual cycle, including the frequency and volume of bleeding, as well as any unscheduled bleeding. Additionally, the study will assess other factors such as acne, mood, sexual function, and menstrual pain using simple questionnaires and scales.
Throughout the study, researchers will also keep track of how well participants adhere to the treatment and whether there are any instances of contraceptive failure, meaning if any participants become pregnant during the study. The study is conducted in Italy and involves women who are in need of contraception. By the end of the study, the researchers hope to gather valuable information about the effectiveness and user experience of the Effimia contraceptive pill.



Italy