Efficacy, Safety, and Tolerability of a New Low-Dose Copper and Nitinol Intrauterine Device: Phase 2 Data to 36 Months.

ABSTRACT:

Objective

To assess in parous and nulliparous women, the efficacy, safety, and tolerability of a new, low-dose copper (175 mm) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded applicator.

Methods

Institutional review boards at 12 U.S. sites approved this commercially funded project. Patients met standard inclusion and exclusion criteria for a copper-based intrauterine device (IUD), generally consistent with the Centers for Disease Control and Prevention's U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Intrauterine device placement occurred at any day in the eligible patient's menstrual cycle after assuring she was not pregnant. The primary outcome measure assessed efficacy (measured by the Pearl Index) in this 1-year study with

SUBMITTER: Turok DK 

PROVIDER: S-EPMC7098438 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature