Clinical trials: Intrauterine Systems
Contraception
A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components
This study is the first study investigating the combined intrauterine administration of LNG (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose finding (DF) study in pre-menopausal women.
- Trial name
- INDessa (NCT03562624)
- Testing
- BAY98-7443, Levonogestrel (Skyla, BAY86-5028)
- Where
- 7 sites in Germany, United Kingdom
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception
LCS16 vs. COC User Satisfaction and Tolerability Study
To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.
- Trial name
- NCT03074045
- Testing
- Levonorgestrel (Kyleena, BAY86-5028), Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
- Where
- 9 sites in Russia
- Volunteers
- 145 people
- Sponsor
- Bayer
Menorrhagia
Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
- Trial name
- NCT00360490
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028), Medroxyprogesterone acetate
- Where
- 54 sites in United States, Argentina and 3 more
- Volunteers
- 165 people
- Sponsor
- Bayer
Hormonal Intrauterine Contraception
The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception
Researchers are looking for better ways to help women prevent pregnancy. Every month, a woman's body prepares for pregnancy in a process called the menstrual cycle. When pregnancy does not happen, menstruation occurs.
- Trial name
- CORA (NCT04785950)
- Testing
- Low-dose levonorgestrel intrauterine systems (LNG-IUS)
- Where
- Spain
- Volunteers
- 316 people
- Sponsor
- Bayer
Contraception
Evaluation of the Efficacy and Safety of LevoCept
To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study
- Trial name
- NCT02882191
- Testing
- LevoCept
- Where
- 16 sites in United States
- Volunteers
- 279 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
Contraception
Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®.
- Trial name
- NCT00185380
- Testing
- Levonorgestrel IUS (BAY86-5028, G04209B), Levonorgestrel IUS (BAY86-5028, G04209C), Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- 35 sites in Finland, Hungary and 3 more
- Volunteers
- 742 people
- Sponsor
- Bayer
Uterine Hemorrhage
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena.
- Trial name
- NCT01295294
- Testing
- Tranexamic acid, Mefenamic acid, Mirena (Levonorgestrel IUS, BAY86-5028)
- Where
- 12 sites in Denmark, Ireland and 1 more
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for…
- Trial name
- NCT00967746
- Testing
- Etonogestrel-releasing IUS, Multiload-cu 375®
- Where
- Germany
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Contraception
To Investigate the Pharmacological Effects, Drug Blood Levels and Safety of an Intrauterine System Releasing the Study Drug BAY1007626 in Comparison to Mirena and Jaydess in Healthy Young Women Treated for 90 Days to Determine the Drug Dose for Further Development
Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the…
- Trial name
- NCT02490774
- Testing
- BAY1007626, Jaydess, Mirena
- Where
- 7 sites in Germany, Netherlands and 1 more
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception
KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method
The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used…
- Trial name
- KYSS (NCT03182140)
- Testing
- Kyleena
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 1,134 people, healthy volunteers welcome
- Sponsor
- Bayer
Menopause
Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age.
- Trial name
- NCT00185458
- Testing
- LNG IUS
- Where
- 12 sites in Belgium, Finland and 2 more
- Volunteers
- 394 people
- Sponsor
- Bayer
Menorrhagia
Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding
The purposes of this study are: To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena. To collect italian data for Mirena in clinical routine.
- Trial name
- NCT00874653
- Testing
- Levonorgestrel (Mirena, BAY86-5028)
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- Bayer
Contraception
LCS12 Adolescent Study
The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age.
- Trial name
- NCT01434160
- Testing
- Skyla (Levonorgestrel, BAY86-5028)
- Where
- 41 sites in Austria, Belgium and 6 more
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception, Women at Risk for Pregnancy
Evaluation of the Efficacy, Safety, and Tolerability of LevoCept
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
- Trial name
- NCT04457076
- Testing
- LevoCept
- Where
- 27 sites in United States
- Volunteers
- 1,525 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
Contraception
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel…
- Trial name
- NCT00528112
- Testing
- LCS12, LCS16
- Where
- 136 sites in United States, Argentina and 9 more
- Volunteers
- 2,885 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception
Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion
To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.
- Trial name
- POST (NCT01958684)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028), Copper-IUD
- Where
- China
- Volunteers
- 512 people
- Sponsor
- Bayer
Uterine Bleeding Profile Prediction
A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor)
Researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods.
- Trial name
- MyIUS (NCT04989595)
- Testing
- MyIUS app
- Where
- 6 sites in Brazil, Denmark and 4 more
- Volunteers
- 3,045 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception, Menorrhagia
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
- Trial name
- NCT00393198
- Testing
- Levonorgestrel (Mirena, BAY86-5028), Cytotec
- Where
- 17 sites in Finland, France and 2 more
- Volunteers
- 204 people
- Sponsor
- Bayer
Contraception
A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.
- Trial name
- NCT05309694
- Testing
- Paragard® T380A Intrauterine Copper Contraceptive with New Inserter
- Where
- 8 sites in United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- CooperSurgical Inc.
Contraception
GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China
The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age.
- Trial name
- NCT00884260
- Testing
- Levonorgestrel IUS (LCS, BAY86-5028)
- Where
- 25 sites in Australia, China and 1 more
- Volunteers
- 918 people, healthy volunteers welcome
- Sponsor
- Bayer