ethinylestradiol; norgestimate for Contraception

Inclusion criteria

• {"criterion_text":"- Healthy women aged between 18 and 35 years (inclusive) in need of contraception.\n- 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.\n- Subjects providing written Informed Consent Form.\n- Subjects willing to comply with the study protocol"}

Exclusion criteria

• {"criterion_text":"- 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conditions should appear during the use of the tested COC, the product must be stopped immediately, and the subject withdrawn from the study.\n- Subjects using COC off-label (e.g., for polycystic ovarian syndrome – PCOS, endometriosis, or recurrent menometrorrhagia).\n- Subjects currently taking part or who took part in clinical studies with experimental products in the previous month.\n- Subjects showing incapacity / inability to comply with the study protocol (unreliability in the intake of the product or in the completion of the diary) according to the Investigator’s opinion.\n- Subjects presenting severe diabetes with blood vessel damages, heart valve disease with complications, severe hypertension, hyperhomocysteinaemia, migraine with aura, hepatitis C (and taking medications for this severe hypercholesterolemia, or hypertriglyceridemia,condition), endometrial hyperplasia, unexplained vaginal bleeding, that are breastfeeding,pregnant or that are suspecting a pregnancy.\n- Subjects presenting (or have ever presented) any liver disease not yet recovered (liver function not yet normalized), any benign or malignant tumour of the liver, any breast orgenital organs cancer (even suspected), jaundice during pregnancy or while using hormonal contraceptives.\n- Subjects presenting galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome.\n- Subjects presenting hypersensitivity to the active substances or to any excipients of the tested COC (e.g., norgestimate, ethinylstradiol or lactose).\n- Subjects using the following not allowed treatments during the whole study period (according to the SmPC of the Investigational Medicinal Product - IMP): treatments for tuberculosis (e.g. rifampicin), for epilepsy (e.g. primidone, phenytoin, barbiturates,carbamazepine, oxcarbazepine), for HIV and hepatitis C virus infection (protease inhibitor drugs and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine,efavirenz and also ombitasvir, paritaprevir, ritonavir and dasabuvir), for fungal infections (e.g. griseofulvin), for arthritis, for osteoarthritis (etoricoxib ), for pulmonary arterial hypertension (bosentan) and St. John's wort used as an antidepressant.Medicines containing cyclosporine, the antiepileptic lamotrigine, tranexamic acid, theophylline (used to treat respiratory problems) and tizanidine (used to treat muscle pain and / or cramps) should not be taken as well.\n- Subjects who have used hormonal contraceptives in the previous month.\n- Subjects presenting a Body Mass Index - BMI ≥ 30 kg/m 2 (class I obesity).\n- Subjects smoking > 15 cigarettes per day."}

Primary endpoints

• {"endpoint_text":"- Cycle control evaluation parameter: breakthrough bleeding (bleeding and/or spotting between cyclically regular onset of menses) by calculating the intermenstrual spotting occurrence rate at sixth cycle only (value to be intended as not cumulative with values from the other 5 cycles taking place during the whole study period). A comparison within group will be performed at V3 with respect to Baseline (V1).","definition_or_measurement_approach":"Calculation of the intermenstrual spotting occurrence rate at the sixth cycle only; within-group comparison at visit V3 versus Baseline (V1)."}

Secondary endpoints

• {"endpoint_text":"- Cycle control evaluation parameters: frequency, duration, regularity, flow volume (subject determined), unscheduled bleeding. A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).","definition_or_measurement_approach":"Assessment of frequency, duration, regularity, subject-determined flow volume and unscheduled bleeding; within-group comparisons at V2 and V3 versus Baseline (V1)."}
• {"endpoint_text":"- Global Acne Grading System (GAGS). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).","definition_or_measurement_approach":"Global Acne Grading System scoring; within-group comparisons at V2 and V3 versus Baseline (V1)."}
• {"endpoint_text":"- Profile of Mood State (POMS). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).","definition_or_measurement_approach":"Profile of Mood State questionnaire; within-group comparisons at V2 and V3 versus Baseline (V1)."}
• {"endpoint_text":"- Female Sexual Function Index (FSFI). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).","definition_or_measurement_approach":"Female Sexual Function Index questionnaire; within-group comparisons at V2 and V3 versus Baseline (V1)."}
• {"endpoint_text":"- Dysmenorrhea - VAS scale. A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).","definition_or_measurement_approach":"Visual Analog Scale for dysmenorrhea; within-group comparisons at V2 and V3 versus Baseline (V1)."}
• {"endpoint_text":"- Compliance (adherence to treatment).","definition_or_measurement_approach":"Adherence measures (study diary/compliance assessments); specific measurement approach not detailed in available data."}
• {"endpoint_text":"- Contraception failure rate during the 6-month treatment; the contraception failure rate is defined as the proportion of women who will become pregnant during the study period. The reasons for any contraception failure occurrence will be identified and listed (e.g., discontinuation or poor compliance).","definition_or_measurement_approach":"Proportion of participants becoming pregnant during the 6-month treatment period; reasons for failures to be identified and listed."}
• {"endpoint_text":"- Metabolic and hormonal parameters","definition_or_measurement_approach":"Assessment of metabolic and hormonal laboratory parameters; specific assays and timing not detailed in available data (note: subgroup of 28 subjects for certain parameters as described in secondary objectives)."}

Italy

Earliest CTIS Part Ii Submission Date

18-11-2024

Latest Decision Or Authorization Date

02-10-2025

Processing Time Days

318

Number Of Sites

6

Number Of Participants

240

Primary sponsor

Full Name

Italfarmaco S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Advice Pharma Group S.r.l.","duties_or_roles":"Sponsor duties codes: 1,10,11,15 (value: Trial StartUp activities),5,6,7,9 (as listed in CTIS thirdParties sponsorDuties)","organisation_type":"Pharmaceutical company"}