PMID- 23228503
OWN - NLM
STAT- MEDLINE
DCOM- 20140407
LR  - 20130514
IS  - 1879-0518 (Electronic)
IS  - 0010-7824 (Linking)
VI  - 87
IP  - 6
DP  - 2013 Jun
TI  - Therapeutically equivalent pharmacokinetic profile across three application sites 
      for AG200-15, a novel low-estrogen dose contraceptive patch.
PG  - 744-9
LID - S0010-7824(12)00970-5 [pii]
LID - 10.1016/j.contraception.2012.10.038 [doi]
AB  - BACKGROUND: AG200-15 Agile Patch (AP) is a novel 7-day contraceptive patch 
      providing ethinyl estradiol (EE) exposure comparable to low-dose combination oral 
      contraceptives. This study determined whether application of the AP to three 
      different anatomical sites (lower abdomen, buttock and upper torso) influences 
      the pharmacokinetic profile of EE and levonorgestrel (LNG). STUDY DESIGN: In this 
      open-label, three-period, crossover study, 24 subjects were randomized to one of 
      six treatment sequences; each included application of patch to abdomen, buttock 
      and upper torso, with the AP worn on one site for 7 days. After a 7-day washout, 
      a new patch was applied to the next anatomical site. Multiple blood samples were 
      collected up to 240 h after patch application. RESULTS: For plasma EE levels, 
      median time to maximum drug concentration (Tmax, 24-48 h) and mean maximum 
      concentration (Cmax, 47.9-61.5 pg/mL) were similar among application sites. 
      Compared with lower abdomen, EE exposure was higher (16%-30%) at buttock and 
      upper torso (15%-22%). For plasma LNG levels, median Tmax (72-120 h) and mean 
      Cmax (1436-1589 pg/mL) were similar across application sites. Compared with lower 
      abdomen, LNG exposure was higher at buttock (1%-7%) and upper torso (16%-17%). No 
      serious adverse events (AEs) or AE-related discontinuations occurred. The most 
      common treatment-emergent AEs were nausea, application site pruritus and 
      headache, with frequencies comparable across anatomical sites. CONCLUSIONS: 
      Absorption from the abdomen was slightly lower versus other sites; however, 
      exposure to EE and LNG for all sites was therapeutically equivalent. The AP was 
      well tolerated at all three anatomical sites.
CI  - Copyright (c) 2013 Elsevier Inc. All rights reserved.
FAU - Stanczyk, Frank Z
AU  - Stanczyk FZ
AD  - University of Southern California, Keck School of Medicine, Los Angeles, CA 
      90089, USA. fstanczyk@socal.rr.com
FAU - Archer, David F
AU  - Archer DF
FAU - Rubin, Arkady
AU  - Rubin A
FAU - Foegh, Marie
AU  - Foegh M
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121208
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Contraceptive Agents, Female)
RN  - 0 (Drug Combinations)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - 5W7SIA7YZW (Levonorgestrel)
SB  - IM
MH  - Abdomen
MH  - Adult
MH  - Buttocks
MH  - Cohort Studies
MH  - Contraceptive Agents, Female/*administration & dosage/adverse 
      effects/blood/*pharmacokinetics
MH  - Cross-Over Studies
MH  - Drug Combinations
MH  - Ethinyl Estradiol/*administration & dosage/adverse 
      effects/blood/*pharmacokinetics
MH  - Feasibility Studies
MH  - Female
MH  - Half-Life
MH  - Headache/chemically induced/epidemiology
MH  - Humans
MH  - Incidence
MH  - Levonorgestrel/*administration & dosage/adverse effects/blood/*pharmacokinetics
MH  - Nausea/chemically induced/epidemiology
MH  - Pruritus/chemically induced/epidemiology
MH  - Skin Absorption
MH  - Thorax
MH  - Transdermal Patch
MH  - United States/epidemiology
MH  - Young Adult
EDAT- 2012/12/12 06:00
MHDA- 2014/04/08 06:00
CRDT- 2012/12/12 06:00
PHST- 2012/08/16 00:00 [received]
PHST- 2012/09/25 00:00 [revised]
PHST- 2012/10/31 00:00 [accepted]
PHST- 2012/12/12 06:00 [entrez]
PHST- 2012/12/12 06:00 [pubmed]
PHST- 2014/04/08 06:00 [medline]
AID - S0010-7824(12)00970-5 [pii]
AID - 10.1016/j.contraception.2012.10.038 [doi]
PST - ppublish
SO  - Contraception. 2013 Jun;87(6):744-9. doi: 10.1016/j.contraception.2012.10.038. 
      Epub 2012 Dec 8.