Original research articleLong-term assessment of symptomatology and satisfaction of an extended oral contraceptive regimen☆
Introduction
Oral contraceptives (OCs) are not only the most common method of reversible contraception in the United States but are used extensively to manage menstrual disorders including endometriosis, dysmenorrhea, menorrhagia and premenstrual symptomatology [1], [2], [3], [4], [5]. Extended OC use is an area of active research in recent years and has become common in actual clinical practice [6], [7]. Many women who are taking OCs in the standard 21/7 manner have cyclic symptoms associated with the 7-day hormone-free interval (HFI) [8].
Numerous investigators have studied extended OC regimens [7], [8], [9], [13], and the first Food and Drug Administration (FDA)-approved extended regimen became available in 2003 (Seasonale®, Barr Laboratories, Pomona, NY, USA). More extended OC products have been submitted to the FDA for approval. Retrospective data in a clinical setting on long-term extended OC use has shown a high acceptance and continuation rate [7], [12]. Prospective data on extended regimens lasting at least 1 year have primarily assessed bleeding [9], [10], [11], [14]. The longest published prospective data is a 2-year extension trial of Seasonale® [15]. While bleeding improved over time, this and other studies have not assessed the long-term effects of common symptoms such as pain, headaches and premenstrual symptomatology over a year-long extended regimen. This 52-week prospective analysis of an extended OC regimen assessed not only daily bleeding occurrence and management but also daily symptomatology of headache, pain and premenstrual symptoms along with long-term satisfaction and continuation 6 months after the 1-year trial.
Section snippets
Methods
This single-center prospective analysis of an extended OC regimen was conducted in two phases. Study Phase 1 was conducted to evaluate short-term effects of an extended OC regimen compared to a standard regimen with two cycles of a 21/7 regimen followed by 168 days (24 weeks) of an extended OC regimen containing 3 mg of drosperinone (DRSP) and 30 μg of ethinyl estradiol (EE) in each active tablet (Yasmin®, Berlex Laboratories, Montville, NJ, USA). Before the completion of Study Phase 1,
Results
Fig. 1 outlines the patient flow of the both Study Phase 1 and 2. Of the 114 subjects who entered the pre-extension 21/7 phase, 111 entered the Study Phase 1 extended OC regimen. Of these, 102 (92%) completed this 168-day extended regimen. Reasons for discontinuing the study are outlined in Fig. 1. Of the 102 women who completed Study Phase 1, 90 were eligible for Study Phase 2, and 86 (96%) enrolled in Study Phase 2. Twelve were not eligible: two for study compliance issues, two for adverse
Discussion
To enter this study, all women had to be OC users for at least 3 months, with many having taken OCs for greater than a year. Before beginning the extended regimen, each woman completed at least 2 months of the study drug in a 21/7 regimen or, if not a DRSP/EE user, a cycle of their original OC followed by two cycles of 21/7 DRSP/EE. Both this study and a previous study [8] document the presence of monthly hormone withdrawal symptoms on 21/7 regimens. While a comparison of 21/7 regimen directly
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Funding for the study was provided by Berlex Laboratories, Montville, NJ, USA.