Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT01534520
Eligibility Criteria:
Inclusion criteria:
* Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age
* Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD)
* No history of pregnancy in the last 6 weeks
* Able to provide written informed consent in English and comply with all study procedures
Exclusion criteria:
* Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics
* Prior failed IUD insertion
* Prior IUD use
* Use of narcotic or benzodiazepine medication within the last 24 hours
* U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD
* Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
14 Years
Maximum Age:
55 Years
Study:
NCT01534520
Study Brief:
Protocol Section:
NCT01534520