RecruitingPhase IVInterventional

DEsogestrel for Bleeding on the Implant (DEBI)

This study, called DEBI, aims to find a better way to help people who experience frustrating bleeding while using the contraceptive implant. The implant is highly effective at preventing pregnancy, but many people have it removed early due to period problems. We're comparing desogestrel, a hormone-only tablet, with the combined oral contraceptive pill (COCP), which contains two hormones. Desogestrel might be safer, cheaper, and easier to access for some. The research wants to see if desogestrel is just as good as the COCP in stopping problem bleeding within 90 days. If it is, it could provide a new, improved treatment option for many implant users.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

University of Nottingham

Enrolment target

690

Start

30 Sep 2025

Estimated completion

31 Oct 2026

Self-reported problem bleeding on the contraceptive implant

What is this study about?

The contraceptive implant is a small rod placed under the skin of your arm that's incredibly good at preventing pregnancy – more than 99% effective. However, a common issue for some people using it is bothersome and unpredictable bleeding or spotting. This can be so frustrating that about a quarter of users decide to have their implant removed early, which can sometimes lead to unplanned pregnancies.

Currently, doctors often suggest taking the combined oral contraceptive pill (COCP) to try and sort out this bleeding. Our study is looking at another treatment option: desogestrel. This is a "mini-pill" that only contains one type of hormone, unlike the COCP which has two. Desogestrel might be a more suitable option for some people, especially those who can't take the combined pill or prefer not to. It's also potentially safer and more affordable, and doesn't require the regular blood pressure and weight checks needed for the combined pill.

The main goal of this research is to see if desogestrel is just as good as the combined pill at reducing problem bleeding within 90 days. If it is, it could mean a simpler, safer, and easier-to-get treatment for people struggling with bleeding while on the implant. This could help more people continue using this very effective form of contraception.

Key takeaways

Exploring new ways to manage problematic bleeding with the contraceptive implant.
Comparing desogestrel (mini-pill) with the combined pill (COCP).
Aims to find a safer, simpler, and more accessible treatment.
Participation involves taking daily tablets and keeping a bleeding diary for 90 days.
No extra clinic visits needed; designed to be easy for participants.

Who may be eligible?

This study is looking for around 690 people who are currently using the contraceptive implant and are experiencing bothersome bleeding. You need to be between 16 and 45 years old and have had your implant in for at least 3 months but no longer than 24 months.

"Problem bleeding" simply means any bleeding (like spotting or heavy bleeding) that you find disruptive or concerning. You'll need to be willing to keep a daily diary of your bleeding throughout the study.

There are some reasons why you might not be able to join, such as if you recently used certain medications or hormones that affect your period, have had certain types of surgery, or have specific medical conditions. The study team will check all these details carefully to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 16 and 45 years old?
Do you currently have a contraceptive implant?
Has your implant been in for at least 3 months, but no more than 2 years?
Are you experiencing bleeding with your implant that you find problematic?
Are you willing to keep a daily bleeding diary?
Can you provide your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly given either desogestrel tablets or combined oral contraceptive pill tablets to take. You'll take these tablets daily for 90 days.

The main thing you'll need to do is keep a simple daily diary about your bleeding throughout this period. The study has been designed to reduce the time commitment for you, so these daily diaries and a few short questions about taking your medication will be the main task. There aren't any extra doctor's appointments or follow-up visits needed for the study beyond your usual care. The total active participation in terms of taking medication and recording information will be mainly for the 90 days.

Potential risks and benefits

Taking part in this study could help us find a better, simpler treatment for implant-related bleeding, potentially benefiting many people in the future. You will receive either desogestrel or the combined pill, which are both established medications for contraception. However, in this study, they are being used specifically to manage implant-related bleeding. Both medications have known side effects, which will be fully explained to you in detail by the study doctor and in the patient information sheets. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Nottingham University Hospitals NHS Trust
City only
Nottingham, England
Leeds Community Healthcare NHS Trust
Approximate
Leeds, England
Cambridgeshire Community Services NHS Trust
City only
St. Ives, England
University Hospitals Sussex NHS Foundation Trust
City only
Worthing, England
Hampshire and Isle of Wight Healthcare NHS Foundation Trust
City only
Southampton, England
University of Nottingham Health Service
Unverified
Nottingham, England
Kingston and Richmond NHS Foundation Trust
Unverified
Kingston upon Thames, England
Northamptonshire Healthcare NHS Foundation Trust
Unverified
Kettering, England
University Hospitals Birmingham NHS Foundation Trust
Unverified
Birmingham, England
Liverpool University Hospitals NHS Foundation Trust
Unverified
Liverpool, England
London North West University Healthcare NHS Trust
Unverified
Harrow, England
The Royal Wolverhampton NHS Trust
Unverified
Wolverhampton, England

Common questions

What is the contraceptive implant?

It's a small, flexible rod placed under the skin of your arm that releases hormones to prevent pregnancy for up to 3 years. It's very effective.

What kind of bleeding is considered 'problem bleeding'?

It's any bleeding, like spotting or heavy periods, that you personally find frustrating or bothersome while using your implant.

Will I know which treatment I'm getting?

The study is 'blinded', meaning you won't know if you're taking desogestrel or the combined pill until the study is over. This helps ensure fair results.

Do I have to visit the clinic often?

No, there are no extra follow-up visits specifically for the study, beyond any appointments you'd usually have with your doctor.

What if I change my mind about participating?

You are free to leave the study at any point, and you don't need a reason. Your usual medical care will not be affected.

How to find out more

Jo Brooks

DEBI@nottingham.ac.uk - Official trial record

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