A study on ovulation inhibition with norelgestromin patch after missed applications in women who need birth control

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What is this study about?

This study is looking at how well a contraceptive transdermal patch called MR-130A-01 works to prevent ovulation when it is not applied exactly as it should be. The patch contains a substance called norelgestromin, which is a type of synthetic progesterone that helps prevent pregnancy by stopping the release of eggs from the ovaries. The study is being done in healthy women who can have children to see if the patch still prevents ovulation even when there are intentional mistakes in how it is applied, such as delays of 24 hours or 48 hours in putting on a new patch.

The purpose of the study is to find out whether the patch continues to prevent ovulation despite these intentional application errors. Participants will use the patch for 84 days, which is about 12 weeks. During this time, they will follow different application schedules that include regular use of the patch, as well as cycles where patches are applied 24 hours late or 48 hours late on purpose. Throughout the study, participants will have regular examinations using transvaginal ultrasound, which is a procedure that uses sound waves to create images of the ovaries and uterus. Blood samples will also be collected to measure hormone levels such as progesterone, estradiol, and luteinizing hormone, which help determine if ovulation has occurred. The study will also check the levels of the medication in the blood and monitor how well the patch sticks to the skin.

The study will track whether ovulation happens during the different application schedules by looking at specific scores and measurements from the ultrasound images and hormone levels. Participants will also be asked to record any bleeding or spotting they experience, and the patch application site will be checked for any skin reactions. The overall safety of the patch will be monitored by recording any unwanted effects that occur during the study. Participants must agree to use non-hormonal methods of birth control, such as condoms or a diaphragm, during the study to prevent pregnancy.

1 Pre-treatment cycle observation

Before starting the treatment, your natural menstrual cycle will be observed to confirm that ovulation occurs normally. This is called the pre-treatment cycle.

Blood samples will be taken to measure progesterone, a hormone that indicates ovulation has occurred. A level above 10.0 nmol/L confirms ovulation.

An ultrasound examination will be performed through the vagina to visualize your ovaries and check that both are visible.

2 Treatment with contraceptive patch – 84 days

You will receive a contraceptive patch called MR-130A-01 that is applied to your skin. The active substance in the patch is norelgestromin.

The treatment will last for 84 days in total, divided into several cycles.

During this period, you will go through different types of cycles: cycles with regular application, cycles with 24-hour application errors, and cycles with 48-hour application errors. The order of these cycles will be determined randomly.

3 Regular application cycles

During regular application cycles, you will apply the patch according to the standard schedule without any intentional delays.

The patch is applied to your skin and remains in place for the designated period before being replaced with a new one.

There will be scheduled patch-free windows, which are periods when no patch is worn.

4 Cycles with intentional 24-hour application errors

During some cycles, you will intentionally delay applying a new patch by 24 hours. This means you will wait an extra day before putting on the next patch.

This intentional error is part of the study design to test whether the patch still prevents ovulation despite the delay.

5 Cycles with intentional 48-hour application errors

During other cycles, you will intentionally delay applying a new patch by 48 hours. This means you will wait two extra days before putting on the next patch.

This intentional error is also part of the study design to test whether the patch still prevents ovulation despite the longer delay.

6 Regular ultrasound examinations

Throughout the 84-day treatment period, you will undergo regular ultrasound examinations through the vagina. These are called transvaginal ultrasound or TVUS.

These examinations will measure the size of follicle-like structures in your ovaries and the thickness of the endometrium, which is the lining of your uterus.

The ultrasound results will be scored using the Hoogland-Skouby score, a system that assesses whether ovulation has occurred.

7 Blood sample collection

Regular blood samples will be taken throughout the study to measure hormone levels.

The hormones measured include luteinizing hormone (a hormone from the pituitary gland that triggers ovulation), estradiol (an estrogen hormone produced by the ovaries), and progesterone (a hormone that rises after ovulation).

Blood samples will also be taken to measure the concentration of norelgestromin and its breakdown product norgestrel in your blood. These measurements will be taken just before applying a new patch and at the end of some patch-free windows.

Specifically, blood will be drawn 5 minutes before applying a new patch and at the end of patch-free windows during cycles with application errors.

Additional blood samples will be taken for safety laboratory tests to monitor your overall health.

8 Patch adhesion assessment

You will be asked to assess how well the patch sticks to your skin using an adhesion score.

The study staff will also assess the patch adhesion during your visits.

9 Skin irritation monitoring

You will monitor and report any skin irritation at the site where the patch is applied.

You will use a scoring system to rate the level of irritation.

10 Bleeding pattern recording

Throughout the study, you will record any bleeding or spotting that occurs.

Information collected will include when bleeding or spotting episodes start and stop, how many days they last, and whether there are any cycles with no bleeding or spotting at all.

11 Use of non-hormonal contraception

Throughout the entire study, you must use reliable non-hormonal contraceptive methods such as male condoms, a diaphragm, or practice heterosexual abstinence.

This requirement does not apply if you or your sexual partner have undergone sterilization.

12 Monitoring for side effects

Throughout the study, any adverse events or side effects you experience will be recorded and monitored.

This includes any new symptoms or health changes that occur during treatment.

Who Can Join the Study?

You must be a healthy woman who has already had your first menstrual period and has not yet reached menopause, which is when monthly periods stop permanently
You must be between 18 and 35 years old
Your body mass index or BMI must be 18.0 or higher, which is a measure calculated from your height and weight
You must be in good physical and mental health based on measurements like blood pressure and heart rate, your medical history, and physical and gynecological examination, which is an examination of your reproductive organs
You must provide written consent after being informed about the benefits and risks of the study
If you have given birth, had an abortion, or stopped breastfeeding, this must have been at least 3 months before joining the study
You must have regular menstrual cycles that last between 21 and 35 days, with both a uterus, which is the organ where a baby grows during pregnancy, and ovaries, which are organs that release eggs
Both of your ovaries must be visible during an ultrasound examination performed through the vagina, which is a test using sound waves to create images of internal organs
You must have an ovulatory cycle before treatment, meaning your body releases an egg, confirmed by a progesterone level greater than 10.0, which is a hormone measured in your blood
You must agree to use reliable non-hormonal birth control methods such as male condoms, diaphragm, or not having sex with men throughout the study, unless you or your sexual partner have had a sterilization procedure to prevent pregnancy

Who Cannot Join the Study?

The study does not provide specific exclusion criteria in the available information
This is a study about contraception, which means birth control methods to prevent pregnancy
The study involves ovulation inhibition, which means stopping the release of eggs from the ovaries
Only women can participate in this study, men are excluded
The study tests what happens when the contraceptive patch is applied incorrectly on purpose, specifically when it is delayed by 24 hours or 48 hours

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Dinox GmbH	Berlin	Germany

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	15.10.2025

Trial locations

MR-130A-01 is a contraceptive patch that you wear on your skin. It works by releasing hormones through your skin to prevent pregnancy by stopping your ovaries from releasing eggs. In this study, researchers want to see if the patch still works to prevent ovulation (egg release) even when it is not applied correctly on purpose, such as being left off for 24 or 48 hours.

Contraception – Contraception refers to the prevention of pregnancy through various methods that interfere with the natural process of conception. In the context of hormonal contraception, synthetic hormones are used to prevent ovulation, which is the release of an egg from the ovary. When ovulation is inhibited, pregnancy cannot occur because there is no egg available for fertilization. Hormonal contraceptives work by affecting the body’s natural hormone levels, particularly those that control the menstrual cycle. The effectiveness of these methods depends on proper and consistent use according to the prescribed schedule. This study examines how well ovulation remains suppressed when application timing errors occur with a contraceptive patch system.

Trial ID:

2025-522565-30-00

Protocol code:

MR-130A-01-TD-2002

Trial Phase:

Therapeutic exploratory (Phase II)

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A study on ovulation inhibition with norelgestromin patch after missed applications in women who need birth control

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?