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

Verified siteInvestigationalNo 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 using a treatment called the Levonorgestrel Vaginal Delivery System 75, also known by its code name CH211-75. The study aims to evaluate how effective, safe, and tolerable this system is as a contraceptive method over the course of 13 menstrual cycles. The Levonorgestrel Vaginal Delivery System is a device designed for vaginal use that releases a hormone called levonorgestrel, which is commonly used in various forms of birth control.

Participants in the study will use the Levonorgestrel Vaginal Delivery System for thirteen 28-day cycles. Throughout the study, researchers will monitor the participants to assess the system's ability to prevent pregnancy and to observe any side effects or changes in health. The study will also look at how the system affects the quality of life and satisfaction of the participants. Additionally, for younger participants, the study will explore any changes in bone health using a method called DXA, which is a type of scan that measures bone density.

The purpose of this study is to demonstrate the contraceptive efficacy of the Levonorgestrel Vaginal Delivery System. Participants will be observed for any adverse events, changes in vital signs, and other health indicators to ensure the safety and tolerability of the treatment. The study will provide valuable information on how well this contraceptive method works and its impact on users' health and well-being.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and screening

    During the initial visit, eligibility for the trial is confirmed. This includes being a sexually active female at risk of pregnancy, either postmenarcheal and premenopausal, including breastfeeding women.

    A written informed consent is required before any trial-related procedures begin. Blood pressure is checked to ensure it is within the acceptable range.

    Participants must agree to use the trial contraception for thirteen 28-day cycles and not participate in any other clinical trials during this period.

  2. Step 2

    Medication administration

    The trial involves the use of a levonorgestrel vaginal delivery system. This is a device used for vaginal use to prevent pregnancy.

    The device is used continuously for thirteen 28-day cycles. Participants are instructed on how to use the device properly.

  3. Step 3

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor health and the effectiveness of the contraceptive method.

    These visits include physical examinations, gynecological examinations, and assessments of any side effects or adverse events.

    Participants are asked about their experiences, including any bleeding or spotting episodes, and their overall satisfaction with the method.

  4. Step 4

    End of trial

    At the end of the thirteen cycles, a final evaluation is conducted to assess the overall experience and effectiveness of the contraceptive method.

    Participants may undergo additional examinations to ensure their health and well-being after the trial.

Who can join the trial?

13 criteria

  • Must be a sexually active female who has started menstruating but has not yet reached menopause. This includes women who are breastfeeding.
  • Must confirm that, to the best of her knowledge, her male partner(s) have not had a vasectomy (a procedure to prevent sperm from being present in semen) or been diagnosed as infertile. This does not apply to adolescents.
  • 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).
  • Females aged 15 to 17 can participate if allowed by local laws and if all legal requirements for consent are met. Special approvals for radiation protection must be confirmed.
  • Must be a woman who either:
    • Has never used hormonal contraceptives before joining the study, or
    • Has used hormonal contraceptives in the past but had a break and a full menstrual cycle without them before joining, or
    • Is switching directly from another hormonal contraceptive.
    • If not pregnant and not using hormonal contraception in the last 6 months, must have regular menstrual cycles (24 to 35 days) during that time.
    • If pregnant in the last 6 months, must have had at least 3 complete menstrual cycles after pregnancy. Breastfeeding women can join 4 weeks after delivery, regardless of menstrual cycles.
    • Must have a systolic blood pressure (the top number) of 140 mm Hg or less and a diastolic blood pressure (the bottom number) of 90 mm Hg or less. Those with controlled high blood pressure can participate.
    • Must provide a written informed consent before any trial-related procedures. This means agreeing to participate after understanding the study details.
    • Must be willing to use the trial contraception method for thirteen 28-day cycles.
    • Must be willing to have intercourse in each cycle of the trial without needing to use additional contraceptive methods. This does not apply to adolescents.

Who cannot join the trial?

3 criteria

  • Participants must be **female**.
  • Participants must be within the age range of **18 to 45 years**.
  • Participants should not be part of a **vulnerable population**. This means they should not be in a situation where they are unable to make fully informed decisions about their participation.
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Investigated drugs

Levonorgestrel Vaginal Delivery System (LVDS) is a form of birth control designed 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 stop the release of eggs from the ovaries and thickens the mucus in the cervix, making it harder for sperm to enter the uterus. The system is used for a set period, typically covering multiple menstrual cycles, and is intended to be a convenient and effective method of contraception.

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 drug 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.

Investigated diseases

Pregnancy – Pregnancy is the condition of carrying one or more embryos or fetuses in the womb. 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 uterine wall, where it develops into an embryo and later a fetus. As pregnancy progresses, the fetus grows and develops, with major organs forming and maturing. The pregnancy typically lasts about 40 weeks from the last menstrual period to childbirth. During this time, the body undergoes various changes to support the developing fetus, including hormonal shifts and physical adaptations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502023-21-00Protocol codeLR-301Estimated enrolment1 037 patientsSponsorChemo Research S.L.

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