Combined Oral Contraceptives (COC) MedDRA version: 20.0 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: EFFIMIA
Product Name: EFFIMIA
Product Code: [NA]
Pharmaceutical Form: Tablet
INN or Proposed INN: Norgestimate
CAS Number: 35189-28-7
Current Sponsor code: 35189-28-7
Concentration unit: m
Sponsors
ITALFARMACO S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the following criteria must be met. • Healthy women aged from 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. 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 228 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 risk of previous deep vein thrombosis (DVT), arterial thromboembolism (ATE), hypertension in course of treatment, 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conditions should appear during the use of the tested COC, the product must be stopped immediately, and the subject withdrawn from the study. • Subjects presenting severe diabetes with blood vessel damages, heart valve disease whit complications, severe hypertension, severe hypercholesterolemia, or hypertriglyceridemia, hyperhomocysteinaemia, migraine with aura, hepatis C (and taking medications for this condition), endometrial hyperplasia, unexplained vaginal bleeding, that are pregnant or that are suspecting a pregnancy. • 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 or genital organs cancer (even suspected), jaundice during pregnancy or while using hormonal contraceptives. • Subjects presenting galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome. • Subjects presenting hypersensitivity to the active substances or to any excipients of the tested COC (e.g., norgestimate, ethinylstradiol or lactose). • 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. • Subjects who have used hormonal contraceptives in the previous month. • Subjects presenting a Body Mass Index - BMI = 30 kg/m2 (class I obesity). • Subjects smoking > 15 cigarettes per day. • Subjects using COC off-label (e.g., for polycystic ovarian syndrome – PCOS, endometriosis, or recurrent menometrorrhagia). • Subjects currently taking part or who took part in clinical studies with experimental products in the previous month. • 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 opini
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •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.;Secondary Objective: •Evaluate the cycle control in terms of frequency, duration, regularity, flow volume (subject determined) and unscheduled bleeding and/or spotting. •Evaluate presence of possible correlations between cycle irregularities and age and / or condition of starter or switcher of contraception. •Evaluate impact on sexual life. •Evaluate impact in subjects affected by pre-treatment acne problems. •Evaluate impact in subjects with premenstrual syndrome (PMS). •Evaluate effects on lipid and glucose metabolism and on hormonal parameters related to hyperandrogenism (by means of calculus of Free Androgenicity Index - FAI) – only in a subgroup of 28 subjects recruited only in the centre of Genova.;Primary end point(s): Primary efficacy outcome •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).;Timepoint(s) of evaluation of this end point: LPLV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy outcomes • 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). • Global Acne Grading System (GAGS). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1). • Profile of Mood State (POMS). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1). • Female Sexual Function Index (FSFI). A comparison within group will be performed at V2 and V3 with respect to Baseline (V1). • Dysmenorrhea - VAS scale. A comparison within group will be performed at V2 and V3 with respect to Baseline (V1). • Compliance (adherence to treatment). • Metabolic and hormonal parameters: blood lipid and glucose parameters (total cholesterol, High Density Lipoprotein – Cholesterol HDL-C, Low Density Lipoprotein – Cholesterol LDL-C, triglycerides, total testosterone, dehydroepiandrosterone - DHEAS, androstenedione, glucose, insulin, Sex Hormone Binding Globulin - SHBG) and hyperandrogenism (Free Androgenicity Index – FAI) – only in a subgroup of 28 subjects recruited only in the centre of Genova. They will be evaluated in comparison with Baseline (V1). Safety outcomes • Adverse events and side effects occurrence assessments.;Timepoint(s) of evaluation of this end point: LPLV | — |
Countries
Italy
Contacts
Public ContactStudy Management Division
OPERA Contract Research Organization Srl
Outcome results
None listed