Evaluating a contraceptive pill's effectiveness and tolerability in Italian women

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.

This study is testing how well the Effimia® contraceptive pill works and how well women aged 18 to 35 in Italy tolerate it, especially looking at issues like breakthrough bleeding.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: Italfarmaco (industry)
• Locations: 1 site (San Martino, Genova)
• Trial ID: NCT06067256 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and tolerability of the monophasic oral contraceptive pill Effimia® (NGM250 + EE35) in a specific group of women aged 18 to 35 residing in Italy. It focuses on evaluating cycle control, particularly breakthrough bleeding, in this population. The study is open-label and non-comparative, meaning all participants will know they are receiving the treatment and there will be no control group for comparison. The research is essential as there have been no recent studies on this contraceptive in Italy.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy women aged 18 to 35 who are in need of contraception and reside in Italy.

Not a fit: Patients with contraindications to Combined Oral Contraceptives or those outside the specified age range will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and tolerability of a contraceptive option for women in Italy.

How similar studies have performed: While this study focuses on a specific contraceptive in Italy, similar studies evaluating contraceptive efficacy have shown success in other populations.

Eligibility criteria

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 withdrawn from the study.
  * Subjects presenting severe diabetes with blood vessel damages, heart valve disease with complications, severe hypertension, severe hypercholesterolemia, or hypertriglyceridemia, hyperhomocysteinaemia, migraine with aura, hepatitis C (and taking medications for this condition), endometrial hyperplasia, unexplained vaginal bleeding, that are breastfeeding or 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 glucosegalactose 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 opinion.

Where this trial is running

San Martino, Genova

• IRCCS Ospedale Policlinico — San Martino, Genova, Italy (RECRUITING)

Study contacts

• Principal investigator: Angelo Cagnacci, MD — IRCCS Ospedale Policlinico San Martino, Clinica Ostetrica e Ginecologica
• Study coordinator: Roberto Piazza, MD

Conditions: Contraception, Female contraception