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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Praxis für Gynäkologie Dr. med. Julia Franke Berlin Germany
Frauenarztpraxis Dr. Inka Kiesche Halle (Saale) Germany
Praxis für Frauengesundheit Dr. med. Stefanie Schultze-Mosgau Hamburg Germany
Lady-Gynec Kft. Budapest Hungary
Mediva s.r.o. Prague Czechia
Stella-Gyn s.r.o. Vodnany Czechia
CARE-MED Bt. Nyiregyhaza Hungary
MUDr. Stepan s.r.o. Hradec Kralove Czechia
Gyncare MUDr. Michael Svec s.r.o. Plzen 2-Slovany Czechia
Centrul Medical Euromed S.R.L. Bucharest Romania
Gyneko spol. s.r.o. Vsetin Czechia
Spitalul Clinic Nicolae Malaxa Bucharest Romania
MUDr. Jaroslav Jenicek, CSc. Prague Czechia
Corti-Med Kft. Gyula Hungary
Zdenek Tesar s.r.o. Prague Czechia
Ordinace MediFem s.r.o. Trnovany Czechia
Gynestar Ordinace s.r.o. Prague Czechia
Gyn Plus s.r.o. Prague Czechia
Gyncentrum Sp. z o.o. Czestochowa Poland
Gyncentrum Sp. z o.o. Bielsko-Biala Poland
Gynecare spol. s.r.o. Puchov Slovakia
Pro Life s.r.o. Komarno Slovakia
Gynedur s.r.o. Dubnica nad Váhom Slovakia
Agaia s.r.o. Martin Slovakia
Mcm Gynped s.r.o. Dubnica nad Váhom Slovakia
Alboran Centro Medico De La Mujer S.L.P. Almeria Spain

Other Sites

Site Name City Country Status
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Axon Kft. Kecskemet Hungary
Spitalul Clinic Filantropia Bucharest Romania
Praxis für Gynäkologie und Geburtshilfe Bernburg Germany
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Spitalul Clinic Judetean Mures Targu Mures Romania
Hospital Quironsalud Barcelona Barcelona Spain
Hospital Quironsalud Marbella Marbella Spain
Hospital Universitario Hm Puerta Del Sur Mostoles Spain
Vita Longa Sp. z o.o. Katowice Poland
Aranyklinika Kft. Szeged Hungary
BKS Research Kft. Hatvan Hungary
Linden Sp. z o.o. sp.k. Cracow Poland
University Of Szeged Szeged Hungary
Hospital Universitario Hm Monteprincipe Boadilla Del Monte Spain
GYNEKOLOGIE Cheb s.r.o. Cheb Czechia
Hospital Quironsalud Valle Del Henares Torrejon De Ardoz Spain
Zrbim Myg Kuur Debrecen Hungary
Tqrvzqn Pkj Kmxo Szekesfehervar Hungary
&dqpchanxds Cayjhlr Mgfxdibljnakeat Azgtivgig Juymxzeycxcjd Fxhp Svxa Cracow Poland
Pdjize Ddh Pzutbw Hamburg Germany
Hsi Skm z oxaq Lublin Poland
Svtqyyllikiemhq Pomlpptj Gqhyrezeejkzxu Jkwcrz Tdaubkrices sanzu Bialystok Poland
Mbgyb Mrcxgox Mwujwwuc Rcweymcymkih sozhxa Plzen Czechia
Cviedwp Mpdcleix Mrrqwhbiew dj Axqt Sddqbxhh Katowice Poland
Qtveumk Mpcazas Cfbxlu Sdcbhv Bucharest Romania
Gkwzjpptrmx Slthejz suzkew Brno-Stred Czechia
Clfbxwa Mncyzfh Dc Dwxmtmkyqf Sm Tlqfdwzus Acyvetygj Nkjvjo Skhzbj Brasov Romania
Koktklqbm snpwaq Nachod Czechia
Swrmird Squhqdeopvxihlk Plbnikdwzho Tofzxq Lereiumw sdfue Rzeszow Poland
Nnp Mnuiooo Cgpmwq Kilt Sopron Hungary
Mlzkahyow Suxxmpvmhc Ule Vilnius Lithuania
Vwvzes Kbjl Szombathely Hungary
Tbuy sroxkn Usti Nad Labem Czechia
Gdoyexmsqrv Shyadjyoup dzt swcjxc Prague Czechia
Dra mpym Soglcm Fcjjjor Aachen Germany
Fzlorpshkdcddoak Dtq Hwyjjcimvjlvexeo Zwickau Germany
Kqijot Grw sfablw Hurbanovo Slovakia
Sjha Mbf sykwfr Banska Bystrica Slovakia
Ajmlr srnptf Turcianske Teplice Slovakia
Idzgkkvx Ufb Kaunas Lithuania
Gyh Mnrn sxjich Ceske Budejovice Czechia
Hazjxyqlrly Ufe Kaunas Lithuania
Mlaltadp szpmui Prague 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 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.

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 ID:
2022-502024-51-00
Protocol code:
LR-302
Trial Phase:
Therapeutic confirmatory (Phase III)

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