Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results☆
Data contained in this report were presented at the annual meeting of the American Society for Reproductive Medicine, Montreal, Canada, October 2005.
Received 30 March 2006; received in revised form 12 July 2006; accepted 12 July 2006. published online 20 September 2006.
Abstract
Objective
This study was conducted to evaluate the safety and efficacy of a continuous daily regimen of levonorgestrel (LNG) 90 μg/ethinyl estradiol (EE) 20 μg (continuous LNG/EE).
Methods
Healthy women aged 18–49 years with regular menstrual cycles for 3 months enrolled in this single-treatment open-label study and took one pill of LNG 90 μg/EE 20 μg daily for 12 months.
Results
For the 2134 subjects enrolled, the Pearl Index method failure was 1.26, and user failure was 0.34. While on Pill Pack 13, 58.7% of subjects reported amenorrhea and 79.0% reported absence of bleeding. Overall, the number of bleeding and spotting days per pill pack declined progressively. Adverse events and discontinuations were comparable to those reported for cyclic oral contraceptive (OC) regimens, except for higher rates in those related to uterine bleeding.
Conclusions
Continuous LNG/EE demonstrated a good safety profile and efficacy similar to cyclic OCs. The regimen continuously inhibited menses, increased the incidence of amenorrhea over time and, except for a subset of women, decreased the number of bleeding and spotting days.
☆ This study (ClinicalTrials.gov; NCT00245921) was supported by a grant from Wyeth Research (Collegeville, PA). Drs. David F. Archer, Jeffrey T. Jensen and Julia V. Johnson were investigators for this study and received research funding from Wyeth Research. Other sources of research funding and/or financial relationships include the following: Agile Therapeutics, Berlex, Genentech, Warner Chilcott, Lilly, Novo Nordisk, Ortho-McNeil, Organon International, Solvay Pharmaceuticals, Barr Laboratories, Duramed Pharmaceuticals, Johnson & Johnson and Wyeth for Dr. Archer; Berlex, Warner Chilcott, Pfizer, Organon International and Barr Laboratories for Dr. Jensen; and Berlex, Novo Nordisk, Pharmacia, Procter & Gamble for Dr. Johnson. Drs. Hannah Borisute, Gary S. Grubb and Ginger D. Constantine are employees of Wyeth Research. Other financial affiliations are Merck, Teva and Johnson & Johnson for Dr. Borisute; and Johnson & Johnson for Dr. Grubb. Dr. Constantine has no financial affiliations.
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