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Study on Menstrual Bleeding and Tolerability of Norgestimate and Ethinylestradiol for Women Using Contraceptives in Italy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a hormonal contraceptive treatment for women. The treatment being tested is a monophasic oral contraceptive pill called Effimia, which contains two active substances: norgestimate and ethinylestradiol. These substances are commonly used in birth control pills to prevent pregnancy. The study aims to evaluate how well this contraceptive controls the menstrual cycle, specifically looking at any unexpected bleeding or spotting that may occur between regular menstrual periods.

The purpose of the study is to understand the pattern of menstrual bleeding, how well the treatment is tolerated, and how consistently it is used by participants. Women participating in the study will take the contraceptive pill for a period of six months. During this time, researchers will monitor various aspects of their menstrual cycle, including the frequency and volume of bleeding, as well as any unscheduled bleeding. Additionally, the study will assess other factors such as acne, mood, sexual function, and menstrual pain using simple questionnaires and scales.

Throughout the study, researchers will also keep track of how well participants adhere to the treatment and whether there are any instances of contraceptive failure, meaning if any participants become pregnant during the study. The study is conducted in Italy and involves women who are in need of contraception. By the end of the study, the researchers hope to gather valuable information about the effectiveness and user experience of the Effimia contraceptive pill.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    The study begins with an initial visit where the participant provides written consent after understanding the study details.

    Eligibility is confirmed based on criteria such as age (18-35 years), health status, and language proficiency.

  2. Step 2

    Baseline assessment

    A baseline assessment is conducted to gather initial data on menstrual cycle characteristics, acne, mood, sexual function, and dysmenorrhea (painful periods).

    This assessment serves as a reference point for future comparisons.

  3. Step 3

    Medication administration

    Participants begin taking the Effimia tablet, which contains ethinylestradiol and norgestimate, orally once daily.

    The treatment is continuous for six cycles, with each cycle lasting approximately one month.

  4. Step 4

    Follow-up visit 1

    A follow-up visit occurs after the second cycle to evaluate changes in menstrual cycle control, acne, mood, sexual function, and dysmenorrhea.

    Data collected is compared to the baseline assessment.

  5. Step 5

    Follow-up visit 2

    Another follow-up visit takes place after the sixth cycle to assess the same parameters as in the previous visits.

    The focus is on breakthrough bleeding, which is any bleeding or spotting between regular menstrual periods.

  6. Step 6

    Final evaluation

    The final evaluation includes a comprehensive review of all collected data to assess the effectiveness and tolerability of the treatment.

    The study concludes with an analysis of compliance and any instances of contraception failure.

Who can join the trial?

5 criteria

  • Participants must be healthy women who are between the ages of 18 and 35 years.
  • Participants must be in need of contraception, which means they are looking for a method to prevent pregnancy.
  • Participants must live in Italy and have a good understanding of the Italian language to ensure they can understand the study details and instructions.
  • Participants must provide a written Informed Consent Form, which is a document that explains the study and confirms their willingness to participate.
  • Participants must be willing to follow the study protocol, which means they agree to follow the rules and procedures of the study.

Who cannot join the trial?

3 criteria

  • Women who are not using any form of contraception cannot participate. Contraception refers to methods used to prevent pregnancy.
  • Men cannot participate in this study.
  • Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may need special protection, like children or people with certain disabilities.
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Investigated drugs

Effimia: This is a monophasic oral contraceptive pill used in the study. It contains two active ingredients, norgestimate and ethinylestradiol, which are hormones that help prevent pregnancy. The study aims to evaluate how well this contraceptive controls menstrual cycles, specifically looking at any unexpected bleeding or spotting that might occur between regular menstrual periods.

What is already known about the treatment

Effimia – Effimia is an oral contraceptive pill taken by mouth, designed to prevent pregnancy in women. It is currently being studied in clinical trials to assess its effectiveness in controlling menstrual cycles and its tolerability among users. The main therapeutic use of Effimia is female contraception. It works by combining two hormones, norgestimate and ethinylestradiol, which prevent ovulation and cause changes in the cervical mucus and uterine lining, making it harder for sperm to reach the uterus and for a fertilized egg to attach. Effimia is classified as a monophasic hormonal contraceptive, meaning it delivers the same dose of hormones throughout the entire cycle.

Investigated diseases

  • Breakthrough Bleeding

    This condition involves unexpected bleeding or spotting between regular menstrual periods. It can occur in women using hormonal contraceptives, such as birth control pills. The bleeding is usually lighter than a normal period and may vary in duration and frequency. It is often a temporary side effect as the body adjusts to new hormonal levels. Over time, the occurrence of breakthrough bleeding may decrease as the menstrual cycle becomes more regulated.

  • Acne

    Acne is a common skin condition characterized by the presence of pimples, blackheads, and cysts. It typically occurs on the face, back, and shoulders due to clogged hair follicles with oil and dead skin cells. Hormonal changes, especially during puberty, can exacerbate acne. The severity of acne can vary, with some individuals experiencing mild outbreaks and others having more severe forms. Acne can lead to skin irritation and, in some cases, scarring if not managed properly.

  • Dysmenorrhea

    Dysmenorrhea refers to painful menstrual cramps that occur before or during a menstrual period. The pain is usually felt in the lower abdomen and can range from mild to severe. It may be accompanied by other symptoms such as nausea, fatigue, and headaches. Primary dysmenorrhea is common in young women and is not associated with any other medical condition. Secondary dysmenorrhea is linked to underlying reproductive system disorders, such as endometriosis or fibroids.

  • Contraception Failure

    This term describes the occurrence of pregnancy despite the use of contraceptive methods. It can result from incorrect or inconsistent use of contraceptives, such as missing birth control pills or improper use of condoms. The effectiveness of contraception varies depending on the method used and adherence to its correct application. Factors such as medication interactions or health conditions can also influence contraceptive effectiveness. Understanding and following the correct usage guidelines can help reduce the risk of contraception failure.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519403-10-00Protocol codeEFFI2021/01Estimated enrolment240 patientsSponsorItalfarmaco S.p.A.

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