Clinical trials: Intrauterine Devices
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
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
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
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.
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
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.
Pregnancy, Ectopic
Occurrence and Trend of Pregnancies Growing Outside the Womb (Ectopic Pregnancy) 2009-2018. A Study on a Defined Group of Persons
In this trial researchers want to learn more about the occurrence of pregnancies growing outside the womb over the last decade (2009-2018) and the potential risk factors associated with pregnancies growing outside the womb.
- Trial name
- NCT03670784
- Testing
- No intervention
- Where
- United States
- Volunteers
- 3,922,877 people
- Sponsor
- Bayer
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
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
Nulliparous
Scandinavian Mirena Insertion Nulliparous Trial.
In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.
- Trial name
- NCT00798980
- Testing
- Mirena (BAY86-5028)
- Where
- Sweden
- Volunteers
- 224 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
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.
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
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.
Women at Risk for Pregnancy
A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)
to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® in Healthy, Post- Menarcheal Women
- Trial name
- IUD (NCT03785366)
- Testing
- VeraCept, ParaGard
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
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
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
Prevention of Pregnancy
Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD
The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the TCu380.
- Trial name
- NCT02167763
- Testing
- VeraCept Intrauterine Copper Contraceptive, TCu380 IUD
- Where
- Dominican Republic
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
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
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