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
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
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.
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
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
Clinically Diagnosed Endometriotic Patient Was Defined as a Woman Who Has Pelvic Pain and at Least One Evidence of PV or TVS
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
The primary objective : To compare effectiveness of pain control in endometriosis associated pelvic pain between LNG-IUS and DMPA The secondary objective : To compare vaginal bleeding pattern, side effect, continuation rate…
- Trial name
- NCT02894151
- Testing
- Depot medroxyprogesterone acetate, LNG-IUS
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
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.
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
Endometriosis
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
randomized controlled trial Eligiblility criteria Provisional diagnosis Clinical presentation Progressive dysmenorrhea Chronic pelvic pain Deep dyspareunia Evidences of endometriosis Endometriotic nodule Cul-de-sac nodularity…
- Trial name
- NCT02534688
- Testing
- LNG-IUS, DMPA
- Where
- Thailand
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- King Chulalongkorn Memorial Hospital
Intrauterine Contraceptive Device Complication
Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device
To evaluate the correlation between uterine artery Doppler indices and subsequent menstrual changes after 3 months of insertion of copper T-380 IUD and LNG-IUS
- Trial name
- NCT05986344
- Testing
- Copper intrauterine contraceptive device, LNG-IUS
- Where
- Egypt
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Beni-Suef University
HIV
Male Engagement in PMTCT Services
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services.
- Trial name
- NCT01903889
- Testing
- clinic based intervention, clinic and community based intervention
- Where
- 7 sites in Uganda
- Volunteers
- 3,806 people, healthy volunteers welcome
- Sponsor
- FHI 360
Menorrhagia, Metrorrhagia
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD).
- Conditions
- Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices
- Trial name
- NCT02824224
- Testing
- Tamoxifen
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Heavy Menstrual Bleeding, Menorrhagia
Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October…
- Conditions
- Heavy Menstrual Bleeding, Menorrhagia, Hypermenorrhea
- Trial name
- Mirena IUD (NCT01391052)
- Testing
- Norethindrone acetate pretreatment, No pretreatment
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Scott and White Hospital & Clinic
Pain Associated With Intrauterine Device Insertion
LI4 Acupuncture for Pain During Intrauterine Device Insertion
This study will evaluate whether acupuncture can reduce pain during intrauterine device (IUD) insertion. Women undergoing IUD insertion will be randomly assigned to receive either real acupuncture at the LI4 point on both hands…
- Trial name
- NCT07854015
- Testing
- LI4 Acupuncture
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Nigde Omer Halisdemir University