Study of dienogest and drospirenone on ovulation inhibition for pregnancy prevention in healthy premenopausal women

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What is this study about?

The study focuses on contraception, which means preventing pregnancy, in healthy premenopausal women. The treatment being examined consists of oral tablets that contain two hormonal ingredients, dienogest and drospirenone. These hormones work together to stop the release of an egg each month, a process called ovulation, thereby providing birth control.

The main aim is to find out how well different dose combinations of the two hormones prevent ovulation when taken as directed and when a dose is missed for about 24 hours. Participants will take the tablets every day for several menstrual cycles, and during the study they will have regular clinic visits where blood samples are taken to measure hormone levels and a simple ultrasound (a safe imaging test that uses sound waves) is performed to look at the lining of the uterus. Any bleeding or spotting is recorded, and safety checks such as basic lab tests are done throughout.

The study lasts for a few months, with participants attending the clinic at set intervals for the examinations and sample collections. All procedures are non‑invasive and designed to monitor how the body responds to the medication while ensuring the participants’ health and safety are closely watched.

1 initial enrollment

after you join the study, you will sign an informed consent form and provide basic health information.

2 baseline assessments

a screening visit will include a physical examination, a transvaginal ultrasound (an imaging test that looks at the uterus and ovaries), and blood tests to measure hormone levels such as estradiol and progesterone.

3 start of treatment cycle 1

you will begin taking one dienogest tablet and one drospirenone tablet by mouth each day.

the tablets are taken at the same time each day for the duration of the first treatment cycle.

4 regular daily intake monitoring

you will record any bleeding or spotting each day in a diary.

clinic visits will be scheduled to check your health, collect blood samples, and perform a transvaginal ultrasound as needed.

5 intentional 24‑hour missed dose

during the study you will be asked to skip taking the tablets for a period of 24 hours and then resume the regular daily schedule.

this step is used to evaluate how a missed dose affects ovulation inhibition.

6 blood sampling for hormone levels

blood will be drawn on day 6 of cycle 1 and on a scheduled day of cycle 2, 24 ± 1.5 hours after the last tablet and within 5 minutes before the next tablet.

additional blood samples will be taken on detection days of cycle 3, 24 ± 1.5 hours after the last tablet and, on another day, 48 ± 1.5 hours after the last tablet before a scheduled double dose.

7 plasma concentration measurements

the study will measure the plasma concentration of dienogest and drospirenone from the blood samples to understand how the medicines are absorbed.

8 assessment of ovulation inhibition

the primary goal is to see whether ovulation (the release of an egg) occurs during treatment cycles 1 through 3.

ovulation is defined by a specific scoring system (Hoogland‑Skouby score 5 or 6).

9 recording bleeding and spotting

you will continue to note any bleeding or spotting episodes throughout cycles 1, 2, and 3.

the total number of episodes, the number of days with bleeding, and the intensity (light, usual, heavy) will be summarized.

10 safety monitoring

at each visit, any adverse events (unwanted effects) will be recorded and routine laboratory tests will be performed to ensure safety.

11 end of treatment and final assessments

after completion of treatment cycle 3, a final set of examinations, including ultrasound, blood hormone measurements, and safety labs, will be performed.

the study will compile all data to determine the overall effect of the medication combinations on ovulation inhibition.

Who Can Join the Study?

Be between 18 and 35 years old when you sign the consent form.
Be a healthy female who has started having periods (post‑menarcheal) and is not yet in menopause (premenopausal).
Be in good physical and mental health, as judged by the doctor through vital signs, medical history, lab tests, and a physical and gynecological exam.
Have a body mass index (BMI) of at least 18.0 kg/m² measured during the screening visit.
Be able to sign the informed consent after understanding the study’s benefits, risks, and insurance coverage.
Be at least 3 months after giving birth, having an abortion, or stopping breastfeeding, if any of these apply.
Have regular menstrual cycles that last 21‑35 days, with an intact uterus and ovaries. If you are using hormonal birth control now, past cycle information can be used.
Both ovaries must be visible on a transvaginal ultrasound (TVUS) exam during the screening visit.
Show an ovulatory cycle before treatment, proven by a progesterone level greater than 10.0 nmol/L.
Agree to use reliable non‑hormonal birth control (male condoms, diaphragm, or abstinence) for the entire study, unless you or your partner are already sterilized.
Agree not to take part in another clinical study or donate blood or plasma while participating in this study.

Who Cannot Join the Study?

Having any severe systemic disease (a serious whole‑body illness) that could affect the study or its results.
Having thyroid dysfunction that is not well controlled (the thyroid gland regulates metabolism). Treated thyroid problems with normal test results may be allowed.
Having diabetes mellitus (high blood sugar).
Having serious problems with lipid metabolism (abnormal fats in the blood).
Having a current or past malignant or premalignant disease (cancer or a condition that could become cancer).
Having health conditions that could worsen with hormone treatment, such as certain pregnancy‑related skin diseases, middle‑ear hearing loss (otosclerosis), movement disorders, blood disorders, autoimmune diseases like systemic lupus erythematosus, or severe allergy conditions.
Being hypersensitive (allergic) to any ingredient of the study medication, including rare sugar‑processing problems such as galactose intolerance, lactase deficiency, or having multiple drug allergies.
Having bone‑loss conditions (osteopenia, osteoporosis), complicated migraine with neurological symptoms, unexplained vaginal bleeding, worsening epilepsy, or inflammatory bowel disease (Crohn’s disease or ulcerative colitis) that could get worse with hormones.
Planning a major surgery or being immobilized for a long time during the study period or within 14 days before screening.
Taking any medicines that could affect how the study drug works, including strong inhibitors or inducers of the enzyme CYP3A4, within 14 days (or five drug half‑lives) before starting.
Taking GLP‑1 receptor agonists or GIP receptor agonists (diabetes medications) within 14 days before starting.
Having disease or abnormal findings in the reproductive organs that could affect safety or drug absorption, such as large fibroids, endometriosis, or thickened uterine lining.
Using a non‑hormonal intrauterine device (copper IUD) unless it is removed before screening, or having used hormonal birth control recently without a proper wash‑out period.
Participating in another clinical study or having used an experimental drug within one cycle (or five drug half‑lives) before the start of this study.
Having a positive pregnancy test at screening.
Having vital signs outside the acceptable range after resting: systolic blood pressure 139 mm Hg, diastolic blood pressure 89 mm Hg, or pulse rate 90 beats per minute.
Having laboratory test results that are abnormal, unless the investigator decides they are not important for the study.
Having hyperkalaemia (high potassium) or conditions that can raise potassium, such as kidney or liver problems, adrenal insufficiency, or taking certain medicines (e.g., ACE inhibitors, potassium‑sparing diuretics, NSAIDs).
Having liver enzymes (ASAT, ALAT) or bilirubin or creatinine levels above the set limits, unless a known harmless condition (e.g., Gilbert’s syndrome) explains it.
Testing positive for HIV, hepatitis B surface antigen (HBs‑AG) or hepatitis C antibodies (anti‑HCV).
Having a recent Pap smear showing abnormal cells higher than grade II‑a (Munich Nomenclature III) within the last 12 months.
Testing positive on a urine drug screen, except for poppy‑seed, alcohol, nicotine, or occasional opiates; any suspected drug or alcohol abuse will be evaluated.
Being obese (BMI ≥ 30 kg/m²) and using tobacco or nicotine products (including e‑cigarettes) within 3 months, as shown by a positive cotinine test.
Having a history of excessive alcohol use or drug abuse.
Being suspected or known not to follow study instructions.
Being unable to understand written or spoken instructions about the study risks and procedures.
Being a dependent person (relative, family member, or staff of the investigator).
Being in custody or under legal authority.
Desiring to become pregnant during the study.
Following a special diet that could affect how the drug is absorbed or processed.
Any other reason the investigator believes would make participation unsafe, non‑compliant, or scientifically unsuitable.

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	Not yet recruiting	10.10.2026

Trial locations

Investigated Drugs:

DROSPIRENONE

Dienogest tablets are taken by mouth and contain a hormone that helps prevent the release of an egg from the ovaries. In this study the tablets were given in different strengths to see how well they stop ovulation when taken correctly and when a dose is missed for 24 hours.

Drospirenone tablets are also taken by mouth and contain another hormone that works together with dienogest to block ovulation. The trial used different strengths of these tablets to test their ability to keep ovulation suppressed during normal use and after a deliberate missed dose.

Contraception (pregnancy prevention) in healthy subjects – Contraception in healthy individuals involves deliberately preventing the release of an egg or the ability of sperm to fertilize an egg, thereby avoiding pregnancy. It typically relies on hormonal methods that suppress the natural menstrual cycle. When the hormonal regimen is taken correctly, ovulation is consistently inhibited across cycles. Missed or delayed doses can allow the hormonal suppression to wane, potentially leading to the return of ovulation. The condition is monitored by tracking hormonal levels and ovarian activity. It is a reversible state that returns to normal reproductive function when the method is stopped.

Trial ID:

2026-526788-39-00

Protocol code:

WHC-545-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of dienogest and drospirenone on ovulation inhibition for pregnancy prevention in healthy premenopausal women

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