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Study on the Effectiveness and Safety of Levonorgestrel Vaginal Delivery System vs. Desogestrel Tablets for Preventing Pregnancy in Women

Fast replyRegistered drugNo 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 the prevention of pregnancy and involves two treatments. The first treatment is the Levonorgestrel Vaginal Delivery System, which is a system designed to release the hormone levonorgestrel directly into the body. The second treatment is a tablet called Desirett 75 Mikrogramm Filmtabletten, which contains the hormone desogestrel. Both treatments are being studied for their effectiveness, safety, and how well they are tolerated by users.

The purpose of the study is to demonstrate the contraceptive effectiveness of the Levonorgestrel Vaginal Delivery System. Participants in the study will be randomly assigned to use either the vaginal delivery system or the oral tablet for nine cycles, each lasting 28 days. The study will compare how well each method prevents pregnancy and will also monitor any side effects or health changes experienced by participants.

Throughout the study, participants will be observed for any adverse events, changes in vital signs, and overall health through physical and gynecological examinations. The study will also assess the quality of life and satisfaction of participants using a questionnaire. The trial aims to provide valuable information on the effectiveness and safety of these contraceptive methods over the course of the study period.

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

    Initial visit and consent

    Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide written informed consent, confirming your understanding and agreement to participate in the trial.

    You will be assessed to ensure you meet the eligibility criteria, which include being a sexually active, postmenarcheal and premenopausal female aged 18 years or older, at risk of pregnancy. Your blood pressure will be checked to ensure it is within the acceptable range.

  2. Step 2

    Randomization and allocation

    After eligibility is confirmed, you will be randomly assigned to one of two groups. One group will use the Levonorgestrel Vaginal Delivery System (LVDS), and the other group will take Desogestrel tablets.

    You will be informed about the method of contraception you have been assigned to and instructed on its use.

  3. Step 3

    Medication administration

    If assigned to the Levonorgestrel Vaginal Delivery System, you will use the vaginal delivery system as instructed for nine 28-day cycles.

    If assigned to the Desogestrel tablets, you will take one tablet orally each day, also for nine 28-day cycles.

  4. Step 4

    Follow-up visits

    Throughout the trial, you will attend regular follow-up visits. These visits will include assessments of your health, any side effects, and the effectiveness of the contraceptive method.

    You may undergo physical examinations, including gynecological exams, and provide blood and urine samples for laboratory tests.

  5. Step 5

    Completion of trial

    After completing the nine cycles, you will have a final visit to assess your overall experience and health status.

    You will be asked to provide feedback on the acceptability of the contraceptive method you used and complete a questionnaire about your quality of life during the trial.

Who can join the trial?

12 criteria

  • Must be a sexually active woman who has started menstruating and has not yet reached menopause, and is at risk of pregnancy. This includes women who are breastfeeding.
  • Must agree not to participate in any other clinical trials during this study, except for non-interventional studies (studies that do not involve active treatment).
  • Must be a woman who either:
    • Has never used hormonal contraceptives before joining the study (naïve users), or
    • Has used hormonal contraceptives in the past but has had a break from them and experienced a full menstrual cycle during this break (previous users), or
    • Is switching directly from another hormonal contraceptive (switchers).
    • If not pregnant and not using hormonal contraception in the last 6 months before joining, must have regular menstrual cycles (between 24 and 35 days) during the last 6 months.
    • If pregnant in the last 6 months before joining, must have had at least 3 complete menstrual cycles after pregnancy. Breastfeeding women can join 4 weeks after delivery, regardless of menstrual cycles after delivery.
    • Must have a systolic blood pressure (the top number in a blood pressure reading) of 140 mm Hg or less, and a diastolic blood pressure (the bottom number) of 90 mm Hg or less. Women with controlled high blood pressure can participate.
    • Must provide a written informed consent before undergoing any trial-related procedures.
    • Must be willing to use the trial contraception assigned to them (either a vaginal ring or oral tablet) for nine 28-day cycles.
    • Must be willing to have intercourse in each cycle of the trial without needing to use additional contraceptive methods.
    • Must be willing to confirm that, to the best of her knowledge, her male sexual partner(s) has not had a vasectomy or been diagnosed as infertile.

Who cannot join the trial?

3 criteria

  • Only females can participate in this study. Males are not eligible.
  • Participants must be within a specific age range. If you are outside this range, you cannot participate.
  • If you are part of a vulnerable population, you may not be eligible. This means groups that might need special protection or care.
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Investigated drugs

  • Levonorgestrel Vaginal Delivery System (LVDS)

    is a form of birth control that is used to prevent pregnancy. It is a small device that is placed inside the vagina, where it slowly releases a hormone called levonorgestrel. This hormone helps to prevent pregnancy by stopping the release of an egg from the ovary and by making it harder for sperm to reach any egg that might be released. The device is designed to be used for a specific period, in this case, 9 cycles, to provide effective contraception.

  • Desogestrel Tablets

    are a type of oral contraceptive pill used to prevent pregnancy. These tablets contain a hormone called desogestrel, which works by stopping the release of an egg from the ovary. It also thickens the mucus in the cervix, making it difficult for sperm to enter the uterus and reach any egg that might be released. This medication is taken daily to provide continuous contraceptive protection.

What is already known about the treatment

  • Levonorgestrel Vaginal Delivery System (LVDS)

    This medication is administered through a vaginal delivery system, which means it is placed inside the vagina to release the hormone levonorgestrel over time. It is currently being studied in clinical trials to assess its effectiveness, safety, and tolerability as a contraceptive method. The main use of LVDS is to prevent pregnancy. It works by releasing levonorgestrel, a hormone that prevents ovulation, thickens cervical mucus to block sperm, and alters the uterine lining to prevent a fertilized egg from implanting. LVDS is classified as a hormonal contraceptive.

  • Desogestrel Tablets

    These tablets are taken orally and contain the hormone desogestrel, which is used to prevent pregnancy. Desogestrel is a well-established medication in the field of contraception and is widely used and documented in medical literature. The primary purpose of these tablets is to prevent pregnancy by stopping ovulation, thickening the cervical mucus to prevent sperm from reaching an egg, and altering the uterine lining to prevent implantation. Desogestrel is classified as a progestin-only contraceptive.

Investigated diseases

Pregnancy – Pregnancy is the condition of carrying a developing embryo or fetus within the female body. It begins with fertilization, when a sperm cell from a male merges with an egg cell from a female, forming a zygote. The zygote implants itself into the lining of the uterus, where it grows and develops over approximately nine months. During this time, the body undergoes various changes to support the growing fetus, including hormonal shifts and physical adaptations. As pregnancy progresses, the fetus develops organs and systems necessary for life outside the womb. The process culminates in childbirth, where the baby is delivered through the birth canal or via cesarean section.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502024-51-00Protocol codeLR-302Estimated enrolment1 356 patientsSponsorChemo Research S.L.

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