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Bleeding patterns with monophasic and triphasic low-dose ethinyl estradiol combined oral contraceptives.

Author(s): Hampton RM, Zhang HF, Barnowski C, Wan GJ

Affiliation(s): Texas Tech University School of Medicine, Odessa, TX 79763, USA. moss.hampton@ttuhsc.edu

Publication date & source: 2008-06, Contraception., 77(6):415-9. Epub 2008 Apr 25.

Publication type: Research Support, Non-U.S. Gov't

BACKGROUND: This retrospective analysis evaluated the association of age and weight with cycle control in women using either of two formulations of low-estrogen-dose oral contraceptives. STUDY DESIGN: Data for this secondary analysis were derived from a randomized multicenter trial assessing the efficacy and safety of norgestimate (NGM) 180/215/250 mcg/ethinyl estradiol (EE) 25 mcg (n=1506) and norethindrone acetate 1 mg/EE 20 mcg (n=1057). In this retrospective analysis, the incidence of breakthrough bleeding/spotting (BTB/S) was evaluated in women stratified by age (18-24, 25-34 and >34 years) and weight (<or=123, 124-155 and >155 lb). RESULTS: A lower percentage of women experienced BTB/S with NGM/EE during most cycles, regardless of age or weight, compared with norethindrone acetate/EE. At Cycle 6, the incidences of BTB/S for NGM/EE versus norethindrone acetate/EE were as follows: 18-24 years, 10.9% versus 29.7% (p<.0001); 25-34 years, 10.9% versus 18.6% (p<.001); >34 years, 8.1% versus 19.1% (p<.005); <or=123 lb, 11.0% versus 25.4% (p<.0001); 124-155 lb, 10.0% versus 22.5% (p<.0001); and >155 lb, 10.0% versus 18.3% (p<.01). CONCLUSION: NGM/EE provided better cycle control as defined by BTB/S compared with norethindrone acetate/EE, regardless of subject age or weight for six cycles.

Page last updated: 2008-06-22

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