Clinical trials: Intrauterine Systems
Mucosal Inflammation, Contraceptive; Complications, Intrauterine
Impact of Contraceptives on Cervico-Vaginal Mucosa
UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood.
- Trial name
- UMPALA (NCT04814927)
- Testing
- Copper IUD, Etonogestrel implant, Levonorgestrel IUS
- Where
- 2 sites in United States, Kenya
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Atypical Endometrial Hyperplasia, Endometrial Adenocarcinoma
Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer
This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer.
- Conditions
- Atypical Endometrial Hyperplasia, Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Stage IA Endometrial Carcinoma
- Trial name
- NCT01943058
- Testing
- megestrol acetate, levonorgestrel-releasing intrauterine system, laboratory biomarker analysis
- Sponsor
- University of Southern California
IUD Insertion Complication, Pain Control
Study of Local Anesthesia as a Method to Decrease IUD Insertion Related Pain
Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive IUDs secondary to the pain associated with insertion.
- Trial name
- NCT01967017
- Testing
- Lidocaine
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Healthy
Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion
The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs.
- Trial name
- NCT00635362
- Testing
- Levonorgestrel-releasing intrauterine system (LNG-IUS)
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University of Chicago
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
Early vs. Interval Postpartum IUD Insertion
Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women who desire intrauterine contraception after delivery.
- Trial name
- EPPIUD (NCT03462758)
- Testing
- IUD
- Where
- 4 sites in United States
- Volunteers
- 404 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Pain
Effect of Intracervical on the Pain Associated With the Insertion of the LNG-IUS
This study has the objective to evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the…
- Trial name
- NCT02155166
- Testing
- Intracervical anesthesia with lidocaine 2%, ibuprofen 400 mg
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Epilepsy, Contraception
Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
The investigators will conduct a prospective, seven-month pilot study to explore pharmacokinetic (PK) and pharmacodynamic (PD) effects among women with epilepsy using the levonorgestrel intrauterine system (LNG IUS) for…
- Trial name
- WESAIL (NCT02362373)
- Testing
- levonorgestrel IUS
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Columbia University
Intrauterine Growth Retardation
Genetic Study of Insulin-Like Growth Factor-I Receptor Mutations in Patients With Intrauterine Growth Retardation
OBJECTIVES: I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead to relative insulin-like growth factor-I insensitivity and produce intrauterine growth retardation in children.
- Trial name
- NCT00005105
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- National Center for Research Resources (NCRR)
Contraception
Immediate Postplacental IUD Insertion
The study will be a randomized clinical trial. Women with less than 10 prenatal visits and/or 2 or more no show visits who desire an Intrauterine Device (IUD) will be considered for enrollment.
- Trial name
- NCT02169869
- Testing
- Mirena, Paragard
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Oregon Health and Science University
Contraception
Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing IUD
Does the addition of cervical lidocaine injections and valium to the current practice result in decreased reported pain with tenaculum placement, IUD insertion, and post procedural discomfort? The current practice is ibuprofen…
- Trial name
- NCT02799641
- Testing
- Diazepam, Lidocaine
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- TriHealth Inc.
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
Undesired Intrauterine Pregnancy, First Trimester Pregnancy
Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions
In the United States, the majority of first-trimester surgical abortions are performed in outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain control.
- Trial name
- NCT01011634
- Testing
- Intravenous moderate sedation versus oral medication
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Contraception
A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA)
The UPA doses to be tested in this new IUS, 5, 20 or 40 μg per day, are not expected to suppress ovulation, however they should prevent endometrial growth resulting in endometrial atrophy, minimal bleeding, or even amenorrhea.
- Trial name
- NCT03230539
- Testing
- Ulipristal Acetate IUS delivering Cu and 5μg, Ulipristal Acetate IUS delivering Cu and 20μg, Ulipristal Acetate IUS delivering Cu and 40μg
- Where
- Dominican Republic
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Population Council
Hemolytic Disease of the Newborn, Fetal Anemia
Neonatal Outcomes on Direct Fetal Intravenous Immunoglobulin During Intrauterine Transfusion for Rhesus Isoimmunization
The goal of this clinical trial is to learn if giving intravenous immunoglobulin directly to the fetus during intrauterine transfusion can improve newborn outcomes in pregnancies affected by rhesus isoimmunization.
- Conditions
- Hemolytic Disease of the Newborn, Fetal Anemia, Rhesus Isoimmunization, Erythroblastosis Fetalis Due to RH Antibodies
- Trial name
- NCT07885592
- Testing
- Intrauterine Transfusion, Intravenous immunoglobulin (IVIG)
- Where
- India
- Volunteers
- 30 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Endometrial Hyperplasia Without Atypia
Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.
- Trial name
- NCT03992937
- Testing
- Vaginal Micronized Progesterone, Levonorgestrel-Intrauterine System
- Where
- Turkey (Türkiye)
- Volunteers
- 132 people
- Sponsor
- Kocaeli University
Pre-Eclampsia, Intrauterine Growth Restriction
PEPPI Study: Identification of Women at Risk for Placental Dysfunction
The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean arterial pressure (MAP) in a…
- Conditions
- Pre-Eclampsia, Intrauterine Growth Restriction, Polycystic Ovary Syndrome, Iron-deficiency
- Trial name
- NCT06115122
- Testing
- Pre-eclampsia screening program
- Where
- Finland
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Oulu University Hospital
Appendicitis, Evidence of Cholecystectomy
Point of Care 3D Ultrasound for Various Applications: A Pilot Study
Summary 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images.
- Conditions
- Appendicitis, Evidence of Cholecystectomy, Gallstones, Pregnancy, Ectopic
- Trial name
- NCT02831556
- Where
- United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Duke University
Pregnancy Related, Immune-mediated Diseases
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy.
- Trial name
- NEWbornIMMPACT (NCT07033663)
- Testing
- Monoclonal antibody
- Where
- 3 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Fundació Sant Joan de Déu
Immediate Postpartum Hemorrhage
Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage
The purpose of this study is to evaluate the impact of early intrauterine tamponade with a Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal delivery and refractory to first-line uterotonic…
- Trial name
- TUB (NCT02226731)
- Testing
- Early Belfort-Dildy Balloon, Late Belfort-Dildy balloon
- Where
- France
- Volunteers
- 405 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris