title: New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study.
abstract: OBJECTIVE
  To evaluate skin irritation and patch adhesiveness of a new weekly low-dose levonorgestrel (LNG) and ethinyl estradiol (EE) contraceptive patch (LNG/EE patch).
  
  
  METHODS
  This analysis was part of an open-label, parallel-group, multicenter, phase 3 study that randomized healthy women to the LNG/EE patch (one patch weekly for three consecutive weeks, followed by a patch-free week for 13 cycles) or to an oral contraceptive for six cycles followed by seven LNG/EE patch cycles. Participants selected patch application sites of abdomen, buttock or upper torso. Investigators rated patch adhesiveness and skin irritation using standardized scales. Participants rated skin irritation and itching daily using standardized scales and recorded patch fall-off on daily diary cards.
  
  
  RESULTS
  A total of 32,508 patches were applied (n=1273). At the five clinic visits in which investigators rated the patches, they rated adhesiveness=0 (no lift) for ≥84% of participants and skin irritation=absent/mild for 97% of patches. Participants reported that 2-3.7% of patches fell off and rated skin irritation as absent or mild for 92- 95% of patches, according to site.
  
  
  CONCLUSIONS
  Investigator- and participant-rated assessments of LNG/EE patch adhesiveness and irritation demonstrated a low incidence of patch detachment, skin irritation and pruritus.
  
  
  CONCLUSIONS
  This secondary analysis of a phase 3 clinical trial of a new weekly low-dose LNG and EE contraceptive patch, which used assessment by both investigators and participants, observed a low incidence of skin irritation, pruritus and patch detachment.
authors.affiliation: Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville, 653-1 West 8th Street, Jacksonville, FL 32209, USA. Electronic address: andrew.kaunitz@jax.ufl.edu.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Kaunitz
authors.affiliation: Columbus Center for Women's Health Research, 99 Brice Road North, Columbus, OH 43213, USA.
authors.forename: David
authors.initials: D
authors.lastname: Portman
authors.affiliation: Mailman School of Public Health, Columbia University, 722 West 168th Street, New York, NY 10032, USA.
authors.forename: Carolyn L
authors.initials: CL
authors.lastname: Westhoff
authors.affiliation: Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, 2020 Zonal Avenue, Room 220, Los Angeles, CA 90033, USA.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Mishell
authors.affiliation: Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, 601 Colley Avenue, Norfolk, VA 23507, USA.
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.affiliation: Department of Pharmacology, New York Medical College, Basic Science Building, 15 Dana Road, Valhalla, NY 10595, USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Foegh
mesh_terms: D000268:Adhesiveness; D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D003877:Dermatitis, Contact / Q000453:epidemiology* / Q000209:etiology; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D015994:Incidence; D016912:Levonorgestrel / Q000008:administration & dosage*; D012108:Research Personnel; D057968:Transdermal Patch / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C072593:ethinyl estradiol, levonorgestrel drug combination; D004997:Ethinyl Estradiol; D016912:Levonorgestrel
keywords: Adhesiveness; Ethinyl estradiol; Itching; Levonorgestrel; Transdermal patch