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AuthorisedTherapeutic use (Phase IV)Interventional

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 checking how a particular type of birth control pill called Effimia works for women in Italy. Researchers want to understand how it affects periods, specifically looking at any bleeding or spotting that happens between usual periods. They are also checking if the pill causes any side effects and if women are taking it regularly as they should. The study will also look at how the pill affects skin (acne), mood, sexual function, and whether it successfully prevents pregnancy. This is a follow-up study for a medicine already in use, to gather more information in a real-world setting.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Italfarmaco S.p.A.
Enrolment target
240
Start
03 Feb 2025

What is this study about?

Imagine a new birth control pill is available, and doctors want to learn more about how it works for real women in everyday life. That's exactly what this study is doing for a pill called Effimia. It's designed to see how this specific birth control pill affects women's periods, whether they experience any unexpected bleeding or spotting, and how well they stick to taking it every day.

The main thing researchers are looking at is 'breakthrough bleeding'. This is when you have some bleeding or spotting in between your regular periods. They will specifically count how often this happens during the sixth month of using the pill. They'll compare this to how things were before the women started the pill. But it's not just about bleeding – they'll also be tracking other period details like how often they come, how long they last, and how heavy they are.

Beyond periods, the study will also check other important aspects of women's health. This includes looking at changes in acne, how mood is affected, and any impact on sexual function. They'll also measure period pain and keep track of how many women get pregnant while using the pill in the study. All of this information helps doctors understand the pill better and gives women clearer expectations.

Key takeaways

  • Study is about a birth control pill called Effimia.
  • Main focus is on how it affects periods, especially spotting.
  • Also looking at mood, skin, sexual health, and pregnancy prevention.
  • Involves taking the pill for six months and clinic visits.
  • For adult women aged 18 and over.
  • Participation is voluntary and you can leave at any time.

Who may be eligible?

To be able to join this study, you need to be an adult woman, at least 18 years old. There's no upper age limit, so as long as you're over 18, you might be able to take part.

The study is specifically for women who are using birth control to prevent pregnancy.

More detailed checks will be done by the study team to make sure it's safe and appropriate for you to participate.

Quick self-check
  • Are you 18 years old or older?
  • Are you female?
  • Are you currently using birth control to prevent pregnancy?
  • Are you able to attend clinic visits over six months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be taking a specific birth control pill called Effimia for six months. You'll have several visits to the clinic (we call these V1, V2, V3) during this time. At these visits, the study team will ask you questions about your periods, any bleeding or spotting you've had, your mood, skin, and sexual health. They will also collect information about your general health. You'll need to keep a diary or record of your bleeding patterns. The total duration of your participation in the study, including all follow-ups, will be for six months.

Potential risks and benefits

Taking part in any study has possible benefits and risks. A potential benefit of this study is that you would receive the Effimia birth control pill, and your health, especially related to your period and overall well-being, would be carefully monitored by medical professionals. Risks could include experiencing side effects from the medication, which will be fully explained to you, although this particular pill is already in use. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Italy

Common questions

What is the main purpose of this study?

The main purpose is to see how a specific birth control pill, Effimia, affects periods, especially unexpected bleeding, and how women use it in real life.

Who can join this study?

Adult women (18 years or older) who are using birth control to prevent pregnancy can join.

How long does the study last?

If you join, you will be taking the birth control pill and monitored for six months.

Will I have to go to clinic visits?

Yes, you will have a few visits to the clinic where the study team will check on your health and ask questions.

What happens if I don't like the pill or want to leave the study?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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