title: Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  Randomized, open-label, parallel-group trial conducted October 1997 to June 1999.
  
  
  METHODS
  Forty-five clinics in the United States and Canada.
  
  
  METHODS
  A total of 1417 healthy adult women of child-bearing potential.
  
  
  METHODS
  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.
  
  
  METHODS
  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 <.001). Only 1.8% (300/16 673) of patches completely detached. Both treatments were similarly well tolerated; however, application site reactions, breast discomfort, and dysmenorrhea were significantly more common in the patch group.
  
  
  CONCLUSIONS
  The contraceptive patch is comparable to a combination OC in contraceptive efficacy and cycle control. Compliance was better with the weekly contraceptive patch than with the OC.
authors.affiliation: The R. W. Johnson Pharmaceutical Research Institute, 920 Route 202, PO Box 300, Raritan, NJ 08869, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Audet
authors.forename: M
authors.initials: M
authors.lastname: Moreau
authors.forename: W D
authors.initials: WD
authors.lastname: Koltun
authors.forename: A S
authors.initials: AS
authors.lastname: Waldbaum
authors.forename: G
authors.initials: G
authors.lastname: Shangold
authors.forename: A C
authors.initials: AC
authors.lastname: Fisher
authors.forename: G W
authors.initials: GW
authors.lastname: Creasy
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000494:pharmacology*; D003276:Contraceptives, Oral / Q000494:pharmacology; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D010349:Patient Compliance; D011247:Pregnancy; D018873:Pregnancy Rate; D011336:Probability; D012306:Risk
chemical_list: D003271:Contraceptive Agents, Female; D003276:Contraceptives, Oral