Clinical Trials Logo

Clinical Trial Summary

This will be a multi-site, participant-blinded, randomized clinical trial. The investigators will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to Mona Lisa NT Cu380 Mini and 200 to ParaGard.


Clinical Trial Description

The total duration of the study for each participant is expected to be approximately 39 months: including screening and enrollment (up to 30 days to meet enrollment criteria), 37 months of participation, and a post-removal follow up telephone call 17 days post-removal. After enrollment, subject visits occur at 6 weeks, 3 months, 6 months, 12 months, 24 months, with telephone calls at 9, 18, and 30 months and seen again at 37 months for their final visit. Subjects will use a home pregnancy test 17 days post-removal of the IUD or Exit Visit procedures, whichever occurs first, and called by the site for the result and for safety follow-up. Subject recruitment is expected to begin Q2 (in the second quarter of) 2017 and is planned to continue through Q2 2018. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q2 2021. The total duration of the study will be approximately 48 months for each study site including pre- and post- trial activities. The end of the study will occur when the last subject to be enrolled has completed her post-removal pregnancy test telephone call. Total duration of the project is expected to be five years. Preliminary results of the study are expected to be available Q4 of 2019 based on the current study plan. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03124160
Study type Interventional
Source Health Decisions
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 26, 2017
Completion date September 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT02575209 - Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects N/A
Completed NCT01879891 - Exercise Intensity, Metabolic Rate and Insulin Sensitivity N/A
Not yet recruiting NCT06395064 - The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial N/A
Completed NCT02720783 - Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary Phase 1
Recruiting NCT04143659 - A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception Phase 1
Completed NCT01764412 - Study of Serum Hepcidin Rate Variations During Menstrual Cycle N/A
Completed NCT05777252 - Effects of 16-Week Circuit Training in Healthy Women N/A
Completed NCT05777265 - The Effects of 16-Week Circuit Training in Healthy Women N/A
Completed NCT03147703 - Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota N/A
Recruiting NCT05994599 - Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring Phase 1
Not yet recruiting NCT03961412 - A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women Early Phase 1
Completed NCT02908503 - Vaginal Film Administration and Placement Study: FLAG N/A
Completed NCT01293591 - Garlic Intake And Biomarkers Of Cancer Risk N/A
Completed NCT02268032 - Assess the Effect of Dehydroepiandrosterone (DHEA) or Other Androgenic Agents Over Markers of Ovarian Reserve Phase 1
Completed NCT02994602 - Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males Phase 1
Completed NCT04189796 - Jarlsberg Cheese Compared to Camembert Cheese N/A
Recruiting NCT03432416 - Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring Phase 2
Unknown status NCT01809405 - Validation of Sexual Function Scale in Female Cancer N/A
Completed NCT03412617 - Diets, Metabolic Profile and Gut Microbiota Among Indonesian Women in Minangkabau and Sundanese-ethnic Community N/A
Completed NCT02112903 - Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women Phase 1