BridgeMD
A multicentre, prospective, open-label, non-comparative study to evaluate menstrual bleeding typology, tolerability, and compliance during a monophasic hormonal contraceptive treatment with norgestimate + ethinylestradiol in Italy.”
EU CTIS ID: 2024-519403-10-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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conditions should appear during the use of the tested COC, the product must be stopped immediately, and the subject withdrawn from the study.
- 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 opinion.
- 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.
- 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.
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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.
- 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 opinion.
- 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.
- 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.
- 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/m 2 (class I obesity).
- Subjects smoking > 15 cigarettes per day.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.