Not recruiting

Study on the Effectiveness and Safety of Mifepristone 50 mg Weekly for Contraception in Women

Fast replyInvestigationalNo placebo

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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 use of mifepristone as a contraceptive. Mifepristone is a medication that is being tested for its effectiveness, safety, and how acceptable it is for use as a once-weekly contraceptive pill. The study aims to understand how well this medication works in preventing pregnancy and to observe any side effects or other health impacts it may have on participants.

Participants in the study will take a 50 mg tablet of mifepristone once a week. The study will monitor the occurrence of pregnancies during the treatment period to evaluate the effectiveness of the medication. Additionally, the study will look at various health aspects, such as changes in liver function, mood, sexual health, weight, and any other side effects that may occur. The study will also assess how participants feel about using mifepristone as their method of contraception.

The trial will last for a period of up to 12 months, during which participants will be asked to keep a daily diary and complete online questionnaires. The study will gather information on the overall experience of using mifepristone as a contraceptive, including any decisions regarding pregnancy continuation or termination, and any related health outcomes. This research will help determine if mifepristone is a viable option for contraception in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on criteria such as age, language proficiency, and health status.
Consent is obtained to participate in the study and to allow access to medical data if complications or pregnancy occur.
Step 2
Medication administration
The study involves taking a medication called mifepristone. This is a tablet taken orally.
The dosage is 50 mg, and it is taken once a week for a duration of 12 months.
Step 3
Daily diary and questionnaires
Participants are required to fill in a daily diary using a study app. This helps track any changes or side effects experienced during the study.
Additionally, participants complete an online questionnaire five times throughout the study period to provide feedback on their experience.
Step 4
Scheduled visits
Regular visits are scheduled to monitor health and ensure adherence to the study protocol.
These visits may include assessments such as ultrasound scans and blood tests to check for any changes in health status.
Step 5
End of study
At the end of the 12-month period, a final visit is conducted to assess the overall experience and gather final data.
Participants may discuss any concerns or questions they have about the study or their health.

Who can join the trial?

13 criteria

Age between 18 and 35 years old at the time of signing the consent form.
Provide informed consent to participate in the study and allow access to medical data if there are complications or pregnancy.
If not using hormonal contraceptives, have a menstrual cycle lasting between 21 and 35 days.
If previously using Depo-Provera (a 3-month injectable contraceptive), have at least 3 cycles of 21 to 35 days after stopping it.
If necessary to use progesterone treatment, be willing to use condoms temporarily.
If 30 years or older, have had a prior HPV (Human Papillomavirus) or Pap test (a test for cervical cancer).
Understand and speak either Dutch or English.
Willing to use mifepristone as the only method of contraception for 12 months. Mifepristone is a medication used for contraception.
Able to take oral medication and willing to follow the study rules.
Have unprotected vaginal heterosexual intercourse with a partner who is not sterilized at least once a month.
Have a BMI (Body Mass Index) of less than 35 kg/m². BMI is a measure of body fat based on height and weight.
Willing to fill in a daily diary using the study app and complete five online questionnaires.
Able to attend scheduled visits and comply with the study protocol.

Who cannot join the trial?

7 criteria

Participants must not be pregnant or planning to become pregnant during the study.
Participants should not have any known allergies to the study medication, which is called mifepristone.
Participants must not have any serious health conditions that could interfere with the study, such as heart disease or liver problems.
Participants should not be using any other form of hormonal contraception during the study.
Participants must not have a history of certain medical conditions, such as unexplained vaginal bleeding.
Participants should not be currently participating in another clinical trial.
Participants must not have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Verified
Amsterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

Mifepristone is a medication being studied for its use as a contraceptive. In this trial, it is taken once a week. Mifepristone works by blocking the hormone progesterone, which is necessary for pregnancy to continue. By doing this, it helps prevent pregnancy. The study is looking at how effective, safe, and acceptable it is for women to use this medication as a form of birth control.

Mifepristone

What is already known about the treatment

Mifepristone – Mifepristone is taken as a pill once a week and is being studied for its use as a contraceptive. Currently, it is in a phase III clinical trial to evaluate its effectiveness, safety, and how well it is accepted by users. The main purpose of mifepristone in this study is to prevent pregnancy. It works by blocking the hormone progesterone, which is necessary for pregnancy to continue. Mifepristone is classified as a progesterone receptor antagonist.

Investigated diseases

Contraception – Contraception is not a disease but a method or device used to prevent pregnancy. It involves various techniques that inhibit the fertilization of an egg by sperm or prevent a fertilized egg from implanting in the uterus. Contraceptive methods can be hormonal, barrier-based, or involve surgical procedures. Hormonal methods, such as pills or injections, alter the body's natural hormone levels to prevent ovulation. Barrier methods, like condoms, physically block sperm from reaching the egg. Surgical options, such as vasectomy or tubal ligation, provide a permanent solution by altering reproductive anatomy.