A novel low-dose copper and nitinol intrauterine contraceptive: Phase 2 clinical trial data with 18-month data
ESC Congress Library. Turok D. May 10, 2018; 208229; ESC50 Disclosure(s): This work is sponsored by Contramed, the company which owns the Veracept IUD. Anita Nelson receives grants from Agile, ContraMed, Estetra SPRL, Evofem Inc,, FHI (for researching MonaLisa), Mathra Pharma, and Merck. She receives honoraria from Allergan, Bayer, and Merck. She serves on advisory boards for Agile, AMAG Pharma, Avior Pharma, Bayer, ContraMed, Merck, and Pharmanest. The University of Utah Department of Obstetrics and Gynecology Program in Family Planning receives research funding from Bayer, Bioceptive, Contramed, Medicines360, Merck, and Teva. David Turok serves on advisory boards for Allergan, Bayer, Pharmanest, and Teva. He is a consultant for Bioceptive and Contamed and a speaker for Allergan, Medicines 360, Merck, and Teva.
Dr. David Turok
Dr. David Turok
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Abstract
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Objectives To assess in a FDA Phase 2 trial with 18-month data, the efficacy, safety, tolerability, and discontinuation rates of a new, low-dose copper (175 mm2) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded tapered applicator. Design and Methods We conducted this single arm Phase 2 FDA trial at 13 sites in the United States. Institutional review boards at the participating sites approved this study. These data report outcomes from the original 1-year study and six months into a two-year extension period. Subjects met standard inclusion/exclusion criteria for a copper IUD, generally consistent with the United States Centers for Disease Control and Prevention Medical Eligibility Criteria for Contraceptive Use. IUD placement occurred any cycle day. The primary outcome measure was pregnancy rate as measured by the Pearl Index. Secondary outcomes included rates of placement success, expulsion, discontinuation rates, serious adverse events, adverse events, and bleeding and spotting patterns. Baseline bleeding information was not collected. We assessed pain at IUD placement using a 5-point Likert Scale (range no pain, very painful). Results A total of 286 women provided 2,475 cycles evaluable for pregnancy at one year. Average age was 27.1 years; 60.8% were nulliparous. There was one pregnancy, Pearl Index =0.54 (95% CI 0.01,2.99). Four participants reported five serious adverse events, but none was study-related. Placement was successful in 283 subjects (98.9%). The majority of participants reported 'no pain' or 'some pain' at placement (63.6%). There were two expulsions (0.7%) and one report of PID. Among participants, 10.6% discontinued early due to adverse events, with 7.7% due to tolerability (bleeding, pain, or cramping); and 7.4% were lost to follow up. Mean number of bleeding or spotting days peaked at Cycle 1 at 11.2 and then declined by Cycle 4 to approximately 7.1, which remained stable through Cycle 13. Mean bleeding-only days peaked at 7.6 for Cycle 1 only and then declined to 5.3 by Cycle 4 for the remainder of the study period. Mean spotting-only days peaked at 3.6 for Cycle 1 only and then declined to 1.7 by Cycle 4 for the remainder of the study period. The first year continuation was 77.4%; with 81.6% of eligible subjects at one year continuing into the long-term study. At 18 months, participants reported no additional pregnancies and two additional expulsions. Conclusions The safety and efficacy characteristics of this novel, low-dose copper intrauterine contraceptive support the appropriateness of a FDA Phase 3 clinical trial.
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