Scheduled and unscheduled bleeding patterns with two combined hormonal contraceptives: application of new recommendations for standardization  

Oleh:

Hampton, Raymond Moss ; Fisher, Alan C. ; Pagano, Susan ; LaGuardia, Katherine D.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Fertility and Sterility (keterangan: ada di ClinicalKey) vol. 92 no. 02 (Aug. 2009), page 434-440.
Topik: Combined hormonal contraceptives; cycle control; ethinyl estradiol; new bleeding pattern criteria; norgestimate; norethindrone acetate; standardization of clinical trial design; unscheduled bleeding

Ketersediaan

Perpustakaan FK Nomor Panggil: F02.K.2009.03 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Objective : To reassess and compare cycle control attained with two combined hormonal contraceptives, norgestimate (NGM)/ethinyl estradiol (EE) 25 µg and norethindrone acetate (NETA)/EE 20 µg, by new general criteria recommendations for all combined hormonal contraceptives. Design : Analysis of bleeding data for cycles 1–6 from a randomized, multicenter trial. Setting : 221 North American centers. Patient(s) : Healthy, sexually active women (18–45 years old). Intervention(s) : NETA/EE: 1 mg NETA/20 µg EE, days 1–21 of each cycle and 75 mg of ferrous fumarate, days 22–28; NGM/EE: triphasic NGM in 7-day increments (days 1–7: 180 µg; days 8–14: 215 µg; days 15–21: 250 µg) and 25 µg EE, placebo on days 22–28. Main Outcome Measure(s) : Cycle control evaluated from patients' daily diaries. Result(s) : For cycles 1–6, there was a statistically significant lower incidence of unscheduled bleeding/spotting with NGM/EE 25 µg (range 21.0%–34.4%) than with NETA/EE 20 µg (range 33.0%–46.6%). Of the women who had unscheduled bleeding/spotting, the mean number of days per cycle of bleeding/spotting was comparable. A statistically significant higher incidence of scheduled bleeding was seen with NGM/EE 25 µg (95.2%–97.5%) than with NETA/EE 20 µg (78.5%–84.2%). Conclusion(s) : The NGM/EE 25 µg has a lower incidence and comparable length of unscheduled bleeding and a higher incidence of scheduled bleeding than NETA/EE 20 µg in this post hoc analysis.

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