title: A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study.
abstract: OBJECTIVE
  To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a patch containing 0.6 mg EE and 6 mg norelgestromin (NGMN).
  
  
  METHODS
  In this phase III, open-label, randomized, parallel-group trial, healthy women aged 18-35 years (smokers aged 18-30 years) received either the EE/GSD patch (n=200) or the EE/NGMN patch (n=198). Treatment consisted of one patch per week for 3 weeks followed by a 7-day, patch-free interval for seven cycles. Bleeding control was assessed in two 90-day reference periods.
  
  
  RESULTS
  In reference period 1, mean number of bleeding/spotting days was comparable across treatment groups (p>0.05). However, in reference period 2, there were fewer bleeding/spotting days in the EE/GSD patch group (15.7 versus 18.4; p<0.0001). Mean number of bleeding/spotting episodes was comparable across groups for both reference periods, but bleeding/spotting episodes were shorter for the EE/GSD patch than the EE/NGMN patch during reference period 1 (5.13 days versus 5.53 days, respectively; p<0.05) and reference period 2 (5.07 versus 5.66; p=0.0001). Both treatment groups showed a similar frequency of withdrawal bleeding episodes; however, across all seven cycles, the length of these episodes was consistently shorter with the EE/GSD patch (p<0.01). There were no notable treatment differences in intracyclic bleeding.
  
  
  CONCLUSIONS
  Bleeding pattern and cycle control achieved with the EE/GSD patch was similar to that of the EE/NGMN patch.
  
  
  CONCLUSIONS
  The paper presents data on the bleeding pattern and cycle control parameters of an investigational transdermal contraceptive patch containing EE and GSD compared with an approved contraceptive patch containing EE and NGMN. This descriptive study found that bleeding patterns associated with the EE/GSD patch were similar to those of an EE/NGMN patch providing higher EE exposure.
authors.affiliation: University Clinic, General Hospital Vienna, Department of Gynecological Endocrinology and Reproductive Medicine, Vienna, Austria.
authors.forename: D
authors.initials: D
authors.lastname: Gruber
authors.affiliation: G-CENTRUM, Olomouc, Czech Republic.
authors.forename: A
authors.initials: A
authors.lastname: Skřivánek
authors.affiliation: Bayer Pharma AG, 13353 Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Serrani
authors.affiliation: Bayer Pharma AG, 13353 Berlin, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Lanius
authors.affiliation: Bayer Pharma AG, 13353 Berlin, Germany. Electronic address: martin.merz@bayer.com.
authors.forename: M
authors.initials: M
authors.lastname: Merz
mesh_terms: D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced / Q000453:epidemiology; D001317:Austria / Q000453:epidemiology; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D018153:Czech Republic / Q000453:epidemiology; D004338:Drug Combinations; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D015994:Incidence; D059373:Mastodynia / Q000139:chemically induced / Q000453:epidemiology; D008595:Menorrhagia / Q000139:chemically induced / Q000453:epidemiology; D008597:Menstrual Cycle / Q000187:drug effects*; D008796:Metrorrhagia / Q000139:chemically induced / Q000453:epidemiology; D009426:Netherlands / Q000453:epidemiology; D009644:Norgestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D009652:Norpregnenes / Q000008:administration & dosage* / Q000009:adverse effects; D010352:Patient Dropouts; D011372:Progestins / Q000008:administration & dosage* / Q000009:adverse effects; D057968:Transdermal Patch / Q000009:adverse effects; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D004338:Drug Combinations; D004967:Estrogens; D009652:Norpregnenes; C511292:Ortho Evra; D011372:Progestins; C033273:Gestodene; D009644:Norgestrel; D004997:Ethinyl Estradiol
keywords: Bleeding pattern; Cycle control; Ethinyl estradiol; Gestodene; Tolerability; Transdermal contraceptive patch