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Contraceptive efficacy, safety and tolerability of drospirenone 4 mg (LPRI‑CF113) in healthy women of reproductive age over 13 cycles

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial evaluates a birth‑control pill called drospirenone (4 mg) combined with a small amount of another hormone, taken by mouth each day. The aim is to show the contraceptive efficacy of this medication, meaning how well it prevents pregnancy in women up to 45 years of age. Effectiveness will be measured using the Pearl Index, a standard way to calculate the number of pregnancies that occur while using the method.

Participants will use the tablet for 13 monthly cycles, roughly a year, and will attend regular clinic visits where simple blood tests, a brief physical exam, and a transvaginal ultrasound may be performed to check health and hormone levels. Throughout the study, any adverse events such as unusual bleeding, pain, or other symptoms will be recorded, and participants will answer short questionnaires about their overall wellbeing and satisfaction with the treatment.

The research process

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

  1. Step 1

    Screening and baseline assessment

    After you join the study, you will undergo screening to confirm that you meet the eligibility criteria, such as age 15‑45 years and not breastfeeding.

    Baseline procedures include a medical history review, physical examination, gynecological examination, transvaginal ultrasound, vital signs measurement, and laboratory tests (blood, urine, and hormone levels).

    The results of these assessments are used to establish your starting health status before you begin the medication.

  2. Step 2

    Starting the medication

    Once you are cleared, you will receive the study medication, identified as lpri‑cf113.

    Each tablet contains drospirenone 4 mg together with an additional 2.8 mg component.

    The tablet is taken by mouth once each day, at the same time each day, for a total of 13 menstrual cycles.

  3. Step 3

    Daily tablet intake

    You will swallow one tablet with water each day, without regard to meals.

    The daily intake continues uninterrupted for the entire 13‑cycle period, unless a study‑provided instruction advises otherwise.

    You should keep a record of any missed doses, bleeding, spotting, or other symptoms and report them at the scheduled visits.

  4. Step 4

    Regular follow‑up visits

    At the end of each cycle (approximately every month), you will attend a clinic visit.

    During each visit, study staff will ask about any adverse events (side effects) you have experienced, and you will complete questionnaires on bleeding patterns and quality of life.

    The visit also includes vital signs measurement, physical and gynecological examinations, transvaginal ultrasound, and laboratory tests (blood count, biochemistry, hormone levels, and urine analysis).

    These assessments help evaluate the safety, tolerability, and contraceptive effectiveness of the medication.

  5. Step 5

    Final assessment and trial completion

    After you have completed 13 cycles of daily tablet use, a final study visit is scheduled.

    The final visit repeats the safety examinations performed during the study (vital signs, physical and gynecological exams, ultrasound, and laboratory tests).

    You will also complete a final questionnaire on medication acceptability and overall satisfaction.

    The information collected at this visit is used to determine the overall efficacy and safety of lpri‑cf113.

Who can join the trial?

11 criteria

  • Be able and willing to give written informed consent (or assent for younger participants) before any study procedures.
  • Be a sexually active woman who is at risk of becoming pregnant and will rely only on the study medication for birth control.
  • Agree not to join any other clinical trials while this study is in progress (non‑interventional studies are allowed).
  • Be sexually active, have started having periods (postmenarcheal), not yet reached menopause (premenopausal), and be between 15 and 45 years old (inclusive) at the screening visit.
  • Have a body mass index (BMI) of 18.5 kg/m² or higher (BMI is a number that compares weight to height).
  • If you are 15‑17 years old, you may join only if local laws allow you to give consent or assent for contraceptive services and all consent rules are followed.
  • Fit into one of the following birth‑control history groups: never used hormonal birth control before (naïve users), used it in the past but stopped and had a full menstrual cycle off the hormone (previous users), or are switching directly from another hormonal birth control method (switchers).
  • Not be pregnant and not have used hormonal birth control in the six months before joining, and have regular menstrual cycles (24‑35 days) during that time.
  • If you were pregnant in the last six months, you must have completed at least three full menstrual cycles after pregnancy; breastfeeding women can join six weeks after delivery even if they have not yet had a period.
  • Have blood pressure measurements within normal limits: systolic (top number) ≤ 140 mmHg and diastolic (bottom number) ≤ 90 mmHg, based on the average of three readings taken after resting.
  • Be willing to use the study medication for thirteen 28‑day cycles.

Who cannot join the trial?

38 criteria

  • Being pregnant now or wanting to become pregnant.
  • Having used alcohol, illegal drugs, or misused prescription medicines in the past 12 months.
  • Having a known HIV infection (a virus that weakens the immune system).
  • Having a known acute or chronic hepatitis B or C infection (viral infections that affect the liver).
  • Having a known HPV infection with high‑risk strains such as 16, 18, or others (a virus that can cause cervical changes).
  • Having taken medication or therapy that is not allowed for the study.
  • Having had fewer than three menstrual periods after stopping depot medroxyprogesterone acetate (Depo‑Provera) or any combined injectable contraceptive.
  • Using any medicine for more than seven days in a month that could lower the effectiveness of hormonal birth control, such as certain seizure medicines, some antibiotics, some heart medicines, St. John’s wort, some HIV medicines, or some hepatitis C medicines.
  • Using medicines that could increase hormone levels, such as certain antifungal drugs, some calcium‑channel blockers, some antibiotics, or drinking large amounts of grapefruit juice.
  • Having received medication that contains human chorionic gonadotropin (hCG) within the month before the first study visit.
  • Having a progestin‑releasing intra‑uterine device (IUD) or contraceptive implant placed within the last two months.
  • Planning to use barrier methods, spermicides, IUDs, or other contraceptives regularly together with the study product.
  • Being unable to follow the study schedule, take the study medication, or use the electronic diary as required.
  • Having a significant psychiatric illness such as major depression or schizophrenia that the investigator feels makes participation unsafe.
  • Planning surgery during the study that would stop use of the study drug.
  • Being a staff member of the study team, sponsor, CRO, or a close family member of those staff.
  • Being in custody or under a court‑ordered institutional placement.
  • Having any condition that the investigator believes could jeopardize safety or the scientific quality of the trial.
  • Having a history of infertility, menopause, or surgical removal of reproductive organs.
  • Having a current male sexual partner who is infertile, has had a vasectomy, or has had both testicles removed.
  • Having a known bleeding disorder or unexplained bleeding or bruising in the past 12 months.
  • Having missed periods (amenorrhea) caused by unknown hormonal or anatomical problems not related to contraception.
  • Having any serious chronic disease or abnormal lab, physical, pelvic, breast, or ultrasound findings that the investigator thinks make participation unsafe.
  • For women 21 years or older, having a Pap smear result of low‑grade squamous intraepithelial lesion (LGSIL) or higher; women under 21 do not need a Pap smear.
  • Having an active blood‑clot disorder (venous thromboembolism) or a family history of such clots in a parent or sibling.
  • Having arterial or cardiovascular disease, such as a heart attack, stroke, or other heart‑blood‑vessel problems.
  • Having had major surgery with prolonged immobilization.
  • Having diabetes that affects the blood vessels.
  • Having severe liver disease (very high liver enzymes or bilirubin) or a history of liver tumors.
  • Having severe kidney failure.
  • Having adrenal insufficiency (the adrenal glands do not make enough hormones).
  • Having a history of hormone‑sensitive cancers, such as breast cancer.
  • Being allergic to the study drug or any of its ingredients.
  • Having headaches that are accompanied by focal neurological symptoms (e.g., weakness, vision changes).
  • Having a history of pancreatitis with very high triglyceride levels.
  • Having gastrointestinal diseases that affect nutrient absorption, such as Crohn’s disease, ulcerative colitis, celiac disease, gastric bypass surgery, or post‑gastric surgery syndrome.
  • Having systemic lupus erythematosus with positive or unknown antiphospholipid antibodies.
  • Having uncontrolled chronic illnesses or an uncontrolled thyroid disorder (thyroid hormone levels not stable for at least two months).
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Investigated drugs

LPRI-CF113 is an oral tablet that contains the hormone drospirenone, which is used to prevent pregnancy. In this study, participants will take the tablet each day for up to 13 menstrual cycles. The trial is looking at how well the medication stops pregnancy, how safe it is, and how comfortable people feel while using it. Researchers will watch for any side effects and record how well the medication works over the study period.

What is already known about the treatment

Drospirenone - It is taken orally as a tablet, usually one 4 mg pill taken each day. Drospirenone is a well‑known synthetic hormone that is already approved and widely used in birth‑control pills. It works by binding to the body’s progesterone receptors to stop ovulation and also blocks a hormone that can cause water retention, helping to prevent pregnancy. In drug classification it is a progestin, a type of hormone used in combined oral contraceptives.

Investigated diseases

No medical condition - The study follows healthy women who do not have a diagnosed disease, observing their normal reproductive physiology and menstrual patterns.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525727-24-00Protocol codeCF113-304Estimated enrolment1 550 patientsSponsorChemo Research S.L.

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