Efficacy, Safety, and Tolerability of a New Low-Dose Copper and Nitinol Intrauterine Device: Phase 2 Data to 36 Months.
CONCLUSION: The novel, low-dose copper and nitinol IUD demonstrated high efficacy and safety in this phase 2 U.S. Food and Drug Administration trial and warrants further expanded study in a phase 3 clinical trial.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02446821.
FUNDING SOURCE: Sebela Pharmaceuticals, Inc.
PMID: 32168217 [PubMed - as supplied by publisher]
Source: Obstetrics and Gynecology - Category: OBGYN Authors: Turok DK, Nelson AL, Dart C, Schreiber CA, Peters K, Schreifels MJ, Katz B Tags: Obstet Gynecol Source Type: research