Clinical trials: Intrauterine Device
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
Intrauterine Devices, Medicated
A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years
A cross-sectional, observational multicenter study to assess the reasons for choosing the 3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years.
- Trial name
- ANALIA (NCT02903888)
- Testing
- Levonorgestrel (Jaydess, Skyla, BAY86-5028)
- Where
- Spain
- Volunteers
- 886 people
- Sponsor
- Bayer
Idiopathic Menorrhagia
Mirena in Idiopathic Menorrhagia
This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four…
- Trial name
- NCT00868153
- Testing
- Levonorgestrel IUS (Mirena , BAY86-5028)
- Where
- 13 sites in Bulgaria, Croatia and 11 more
- Volunteers
- 1,125 people
- Sponsor
- Bayer
Postoperative Adhesion of Uterus
Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.
- Trial name
- NCT04007211
- Testing
- ABT13107, Hyalobarrier
- Where
- South Korea
- Volunteers
- 192 people
- Sponsor
- Medy-Tox
Contraception
HR-QoL and Sexuality in Mirena Inserted Contraception Users
The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use.
- Trial name
- NCT00498784
- Testing
- Mirena
- Where
- France
- Volunteers
- 141 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
Contraceptive; Complications, Intrauterine
Surveillance Study of the Contraceptive Intrauterine Device UT380®
The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.
- Trial name
- CCDDIUUT (NCT03642171)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Quanta Medical
Reversible Prevention of Pregnancy
A Study on the Safety and Efficacy of the SCu300A IUB Compared to the TCu380 Copper IUD
This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD compared to the standard T shaped copper IUD, the TCu380.
- Trial name
- NCT02036203
- Testing
- SCu300A IUB, TCu380A IUD
- Where
- Israel
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Contraception
A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device
Current intrauterine devices (IUD) pose such risks as uterine perforation during insertion, malposition and expulsion. The investigated device, the IUB(tm) SCu300A is an IUD which is inserted in a similar fashion into the uterus…
- Trial name
- NCT01590563
- Testing
- IUD
- Where
- Hungary
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Medicated Intrauterine Devices, Contraception
Mirena Efficiency and Tolerability During the First Year of Use
In this trial the efficacy and safety of Mirena was investigated during the first year of use
- Trial name
- NCT00696202
- Testing
- Mirena (BAY86-5028)
- Where
- France
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- Bayer
Contraception
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.
- Trial name
- DIUQoL (NCT01731132)
- Testing
- Levonorgestrel IUD or Copper IUD
- Where
- Spain
- Volunteers
- 207 people
- Sponsor
- Bayer
Contraception
IUB(TM) SCu300B - Post Marketing Performance Study in Austria
Participating investigators will locate all IUB B insertions conducted at their facility at least 12 month prior the initiation of study data collection. The study is composed of 2 parts.
- Trial name
- NCT02778061
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
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
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
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- 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.
To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
- Trial name
- NCT02036177
- Testing
- SCu300A IUB intrauterine device, T380A IUD
- Where
- 2 sites in Bulgaria, Romania
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Copper Intrauterine Device Induced Bleeding
Study About Patients Using Copper Intrauterine Device
THE AIM OF THE this study is to assess the hemodynamic changes of uterine artery in patients with CIUD induced bleeding by using transvaginal color Doppler indices (uterine artery resistance index and pulsatility index) to prove…
- Trial name
- IUD (NCT01541241)
- Where
- Egypt
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Egymedicalpedia
Pain
Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion
The purpose of this study is to evaluate the efficacy and safety of DEC103 in the pain control associated with IUD insertion in women with 18 to 49 years.
- Trial name
- DEC103 (NCT05800392)
- Testing
- DEC103
- Where
- Brazil
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- EMS