title: Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study.
abstract: OBJECTIVE
  The aim of this study was to investigate the bleeding pattern and cycle control of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a combined oral contraceptive (COC) containing 0.02 mg EE and 0.1 mg levonorgestrel (LNG).
  
  
  METHODS
  In this phase III, randomized, controlled, double-blind, double-dummy, multicenter trial, healthy women aged 18-45 years (smokers aged 18-35 years) received either the EE/GSD patch and a placebo tablet (n=171), or a placebo patch and the COC (n=175) for seven 28-day cycles. Bleeding control was assessed in two 90-day reference periods.
  
  
  RESULTS
  Mean number of bleeding/spotting days was comparable across treatment groups in both reference periods (p>.05). Mean number of bleeding/spotting episodes was also comparable in reference period 1; however, there were fewer bleeding/spotting episodes for COC in reference period 2 (3.4 versus 3.1; p=.01). Mean length of bleeding/spotting episodes was comparable across treatment groups for both reference periods (p>.05). Withdrawal bleeding occurred consistently in both groups over the entire treatment period, but its absence was more common in the COC group in cycles 4 and 6 of reference period 2 (p<.01). Intracyclic bleeding was comparable between groups.
  
  
  CONCLUSIONS
  Bleeding pattern and cycle control with the EE/GSD patch was comparable to an EE/LNG-containing COC.
  
  
  CONCLUSIONS
  The findings suggest that bleeding patterns with the EE/GSD patch are similar to an EE/LNG-containing COC, except for absence of withdrawal bleeding, which was less common in patch users. The EE/GSD patch may constitute an additional contraceptive option for women.
authors.affiliation: Bayer Pharma AG, 13353 Berlin, Germany. Electronic address: martin.merz@bayer.com.
authors.forename: M
authors.initials: M
authors.lastname: Merz
authors.affiliation: Women's Clinical Research Center, Seattle, WA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Kroll
authors.affiliation: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ, USA.
authors.forename: R
authors.initials: R
authors.lastname: Lynen
authors.affiliation: Bayer Pharma AG, 13353 Berlin, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Bangerter
mesh_terms: D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects; D008595:Menorrhagia / Q000139:chemically induced; D008597:Menstrual Cycle / Q000187:drug effects*; D008796:Metrorrhagia / Q000139:chemically induced; 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; D014481:United States; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D004967:Estrogens; D009652:Norpregnenes; D011372:Progestins; C072593:ethinyl estradiol, levonorgestrel drug combination; C033273:Gestodene; D004997:Ethinyl Estradiol; D016912:Levonorgestrel
keywords: Bleeding pattern; Contraceptive patch; Cycle control; Female contraception; Transdermal