2024-519403-10-00招募中4 期
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.”
Italfarmaco S.p.A.6 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年2月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- 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).
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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conditions should appear during the use of the tested COC, the product must be stopped immediately, and the subject withdrawn from the study.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.
结局指标
主要结局
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).
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).
次要结局
- 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).
- 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).
- Metabolic and hormonal parameters
研究者
Roberto Piazza
Scientific
Italfarmaco S.p.A.
研究点 (6)
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