A Multicentre, Prospective, Open-label, Non-comparative Study

September 28, 2023 updated by: Italfarmaco

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.

As there are no recent studies conducted in Italy on the profile of this COC, the purpose of this study is to evaluate its efficacy and tolerability in a given subset of women residing in Italy that are in need of contraception. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Genova
      • San Martino, Genova, Italy
        • Recruiting
        • IRCCS Ospedale Policlinico
        • Contact:
          • Angelo Cagnacci, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycle control evaluation parameter
Time Frame: 180 days
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)
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycle control evaluation parameters
Time Frame: 180 days
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).
180 days
Global Acne Grading System (GAGS).
Time Frame: 180 days
A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
180 days
Profile of Mood State (POMS).
Time Frame: 180 days
A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
180 days
Female Sexual Function Index (FSFI).
Time Frame: 180 days
A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
180 days
Dysmenorrhea - VAS scale.
Time Frame: 180 days
A comparison within group will be performed at V2 and V3 with respect to Baseline (V1)
180 days
Compliance
Time Frame: 180 days
Adherence to treatment
180 days
Contraception failure rate during the 6-month treatment
Time Frame: 180 days
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).
180 days
Metabolic and hormonal parameters
Time Frame: 180 days
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).
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italfarmaco

Investigators

  • Principal Investigator: Angelo Cagnacci, MD, IRCCS Ospedale Policlinico San Martino, Clinica Ostetrica e Ginecologica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFFI2021/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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