Clinical trials: Contraceptive Device; Intrauterine
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
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, 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
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
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
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
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.
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.
Contraception
Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception
Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a Phase III Clinical Study
- Trial name
- NCT02446821
- Testing
- VeraCept
- Where
- 12 sites in United States
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
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.
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
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
Contraception
LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months.
- Trial name
- NCT01254292
- Testing
- Levonorgestrel IUD (LCS, BAY86-5028), Yasmin (EE30/DRSP, BAY86-5131)
- Where
- 94 sites in United States, Austria and 3 more
- Volunteers
- 567 people
- Sponsor
- Bayer
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.
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.
Women at Risk for Pregnancy
Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS
To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept
- Trial name
- NCT03633799
- Testing
- VeraCept
- Where
- 41 sites in United States
- Volunteers
- 1,620 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
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
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
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