Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive - A randomized controlled trial
Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive - A randomized controlled trial
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DOI：
10.1001/jama.285.18.2347
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发表时间：
2001-05-09
影响因子：
120.7
通讯作者：
Creasy, GW
中科院分区：
文献类型：
--
作者：
Audet, MC;Moreau, M;Creasy, GW
Context Oral contraceptive (OC) pills are effective, but poor compliance increases rates of pregnancy during treatment.Objective To compare the contraceptive efficacy, cycle control, compliance, and safety of a transdermal contraceptive patch and an OC,Design Randomized, open-label, parallel-group trial conducted October 1997 to June 1999.Setting Forty-five clinics in the United States and Canada.Participants A total of 1417 healthy adult women of child-bearing potential.Interventions Participants were randomly assigned to receive a transdermal contraceptive patch (n=812) vs an OC (n=605) for 6 or 13 cycles. Patch treatment consisted of application of 3 consecutive 7-day patches followed by 1 patch-free week.Main Outcome Measures Overall and method-failure Pearl Indexes (number of pregnancies/100 person-years of use) and life-table estimates of the probability of pregnancy were calculated. Cycle control, compliance, patch adhesion, and adverse events were also assessed.Results Overall and method-failure Pearl Indexes were numerically lower with the patch (1.24 and 0.99, respectively) vs the OC (2.18 and 1.25, respectively); this difference was not statistically significant (P=.57 and .80, respectively), The incidence of breakthrough bleeding and/or spotting was significantly higher only in the first 2 cycles in the patch group, but the incidence of breakthrough bleeding alone was comparable between treatments in all cycles. The mean proportion of participants' cycles with perfect compliance was 88.2% (811 total participants, 5141 total cycles) with the patch and 77.7% (605 total participants, 4134 total cycles) with the OC (P
