A pivotal, multicentre, randomised, open-label, parallel-group trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 9 cycles in comparison with Desogestrel tablets 0.075 mg.
This study is looking at two types of contraception: a new levonorgestrel vaginal ring and a desogestrel tablet, which is a common birth control pill. We want to find out how effective each one is at preventing pregnancy in women under 35 who are not breastfeeding. We're also checking for any side effects or discomfort. This is a large study (Phase III) involving many centres, which helps us understand how these methods work in a real-world setting. The goal is to provide valuable information about these contraceptive options.
At a glance
What is this study about?
This study is a research project designed to compare two different methods of contraception for preventing pregnancy. One method is a new system that delivers a hormone called levonorgestrel through a vaginal ring. The other method is a desogestrel tablet, which is a standard birth control pill available now. The main goal is to see which method is better at preventing pregnancy over nine monthly cycles. We're also very interested in how safe and comfortable each method is for the women taking part.
Researchers will be looking closely at how many pregnancies occur in each group of women. This helps them understand how effective each contraceptive truly is. They will also carefully record any side effects or health changes experienced by the participants, like changes in bleeding patterns, general well-being, and results from examinations. This information is important for understanding the overall comfort and safety of the treatments.
This is a 'Phase III' study, which means it's a large, important step in testing new medicines or devices. These types of studies are done after earlier research has shown a treatment is promising. The results from this study will help doctors and women make informed choices about contraceptive options in the future.
Key takeaways
- Compares a new vaginal ring with a common birth control pill for preventing pregnancy.
- Aims to understand how effective and safe each method is.
- Involves women 18 years and older who are not breastfeeding.
- Participation lasts for about nine months with regular health check-ups.
- Carefully monitors for any side effects and overall well-being.
Who may be eligible?
To be able to join this study, you must be a woman aged 18 years or older. There is no upper age limit, meaning older women can also participate if they meet other criteria.
You should also be able to understand the study requirements and be willing to follow them for the entire duration of the trial.
Specific details about your health and medical history would be discussed with the study team to confirm you are a good fit for this research. For example, the main part of the study focuses on women who are not breastfeeding.
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 female?
- Are you 18 years old or older?
- Are you currently not breastfeeding?
- Are you able to attend regular appointments for about nine months?
- Are you comfortable using contraception, either a pill or a vaginal ring?
What does participation involve?
If you decide to take part in this study, you'd be assigned to one of two groups: either using the new levonorgestrel vaginal ring or taking the desogestrel birth control pill. You would use your assigned contraception for nine monthly cycles, which is about nine months.
During this time, you would have regular appointments at the study clinic. These visits would involve health checks, including physical exams, blood pressure measurements, and possibly gynaecological examinations with an ultrasound. You might also be asked about any side effects you experience or changes in your bleeding patterns.
Researchers will closely monitor your health and how well the contraception is working throughout the study. The total duration of your involvement would be approximately nine months, plus any initial screening and final follow-up appointments.
Potential risks and benefits
Locations (8)
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedLithuania
- —UnverifiedSlovakia
- —UnverifiedRomania
Common questions
What is a 'vaginal delivery system'?
It's like a soft ring that you place inside your vagina. It slowly releases hormones that help prevent pregnancy.
What does 'non-breastfeeding women' mean for this study?
It means the study is looking at women who are not currently breastfeeding a baby.
What is a 'Pearl Index'?
The Pearl Index is a way of measuring how effective a birth control method is. A lower number means it's more effective.
Will I know which type of contraception I'm getting?
Yes, this is an 'open-label' study, which means both you and the study team will know whether you are using the vaginal ring or the pill.
How long will I be in the study?
You would be in the study for about nine months, plus a little extra time for initial checks and follow-up.
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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