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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Gyncentrum Sp. z o.o. Katowice Poland
C.M.I. OBSTETRICA GINECOLOGIE – NEAMTU LUCIAN-RADU Craiova Romania
Praxis Dr. med. Frommeyer Osnabrück Germany
Centro de Salud La Roca – Unidad de Salud Sexual y Reproductiva Malaga Spain
Stella-Gyn s.r.o. Vodnany Czechia
Centrul Medical Euromed S.R.L. Bucharest Romania
Spitalul Clinic Nicolae Malaxa Bucharest Romania
Mediva s.r.o. Prague Czechia
CARE-MED Bt. Nyiregyhaza Hungary
Lady-Gynec Kft. Budapest Hungary
Centrul Medical Pirtea S.R.L. Timisoara Romania
Gyvenk Silciau UAB Vilnius Lithuania
OB/GYN Associates s.r.o. Prague Czechia
Javorka s.r.o. Ruzomberok Slovakia
Agaia s.r.o. Martin Slovakia
Pro Life s.r.o. Komarno Slovakia
Frauenarztpraxis Wandsbek Hamburg Germany
Praxis Geseke Geseke Germany
Niepubliczny Zaklad Opieki Zdrowotnej Medem Wilk Sp. j. Katowice Poland

Other Sites

Site Name City Country Status
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Axon Kft. Kecskemet Hungary
Semmelweis University Budapest Hungary
Spitalul Clinic Filantropia Bucharest Romania
Saules seimos medicinos centras UAB Kaunas Lithuania
Hospital General Universitario De Valencia Valencia Spain
Sana Monitoring S.R.L. Bucharest Romania
Spitalul Municipal Caracal Caracal Romania
Hospital Quironsalud Malaga Malaga Spain
Aranyklinika Kft. Szeged Hungary
Centrum gynekologicke rehabilitace s.r.o. Písek Czechia
D I A T R O S Diagnosticos Y Tratamientos Avanzados S.L.P. Gava Spain
Gttgnvyzzipwpdof Zonnmci Brhq Bonn Germany
Mhkas Irjdc Sayfzratlu smpxok Vysoke Myto Czechia
Gtysypfivtz Suwbjbc seqqyh Brno-Stred Czechia
Gtfwoosmcn Sle z owzd Cracow Poland
Pppwoe Dxf Pxwtlr Hamburg Germany
Ajwup Gbylgaebex Granollers Spain
Zkmmz Mbg Ktiw Debrecen Hungary
Tlqiyaqhyk Mospgwjfdqjxj Ztox Budapest Hungary
Tjupbmi Pzz Kcco Szekesfehervar Hungary
Qynuodx Miujrlp Coksrb Sbepxy Bucharest Romania
Clymmav awtxkbtagi gelhhemevtl a peevowyw plyv saaunv Brno-Stred Czechia
G Cmsyynn Okcydun smwuyg Olomouc Czechia
Gxvvyn srvbzc Nove Mesto Nad Vahom Slovakia
Hcv Spp z ozlc Lublin Poland
Seyihhcynanwspu Pspjcpwf Gigdegmwjqdeqm Jriplf Tgmgodhnoex sxclm Bialystok Poland
Mncyfjb Mfv Skbpvj Bucharest Romania
Sbnclpdm Jxhu Uzt Vilnius Lithuania
Gnemxhrnygg Kanklaa sqyqlq Podebrady Czechia
Aerls srufyr Turcianske Teplice Slovakia
Kbhrylq Meoqgnrtml Ixhiyhoh Dmpvembbdby I Lescsoll Nhyhebtutfvc Cracow Poland
Noo Mbn Kalw Debrecen Hungary
Gus Mwcx sulfpd Ceske Budejovice Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
15.05.2023
Germany Germany
Not recruiting
15.05.2023
Hungary Hungary
Not recruiting
15.05.2023
Lithuania Lithuania
Not recruiting
15.05.2023
Poland Poland
Not recruiting
15.05.2023
Romania Romania
Not recruiting
15.05.2023
Slovakia Slovakia
Not recruiting
15.05.2023
Spain Spain
Not recruiting
15.05.2023

Trial locations

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.

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 ID:
2022-502023-21-00
Protocol code:
LR-301
Trial Phase:
Therapeutic confirmatory (Phase III)

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