PMID- 20544040
OWN - NLM
STAT- MEDLINE
DCOM- 20100715
LR  - 20131121
IS  - 1533-7294 (Electronic)
IS  - 0094-3509 (Linking)
VI  - 59
IP  - 5
DP  - 2010 May
TI  - A look at the long-term safety of an extended-regimen OC.
PG  - E3
AB  - BACKGROUND: Oral contraceptives (OCs) are the most widely used method of 
      reversible contraception. Recent alterations of the standard 28-day regimen have 
      included shortening the traditional hormone-free interval (HFI), supplementing 
      the HFI with low-dose estrogen, or increasing the number of active pills 
      administered, thus extending the time between withdrawal bleeding episodes by a 
      variable number of months. In light of these changes in regimens, clinicians may 
      be seeking evidence that the new regimens are safe and will not result in 
      unexpected adverse events. METHODS: We initiated a long-term extension trial to 
      evaluate the safety of a 91-day extended-regimen OC containing 150 mcg 
      levonorgestrel/30 mcg ethinyl estradiol (EE) for 84 days, followed by 7 days of 
      10 mcg EE. After participation in a 1-year, open-label, phase 3 contraceptive 
      program, 320 women qualified for enrollment in a multicenter, nonrandomized study 
      of 91-day extended-regimen OCs for up to 3 additional consecutive years; 116 
      completed the study. We evaluated incidence of reported adverse events (AEs), 
      rates of study discontinuation, and reported bleeding patterns. RESULTS: Total 
      exposure was equivalent to 8292 28-day cycles. Participants reported no 
      thromboembolic events. Thirty-one (9.7%) women discontinued treatment due to AEs. 
      Unscheduled bleeding and spotting diminished during the course of the trial. 
      Overall rates of study discontinuation and incidence of AEs were consistent with 
      those observed in the phase 3 clinical program. CONCLUSION: This study 
      demonstrated that the AE profile of the 91-day extended-regimen OC over 4 years 
      was similar to that seen in the 1-year clinical trials, with no unexpected 
      adverse events.
FAU - Davis, Matthew G
AU  - Davis MG
AD  - Rochester Clinical Research, Inc., Rochester, NY, USA.
FAU - Reape, Kathleen Z
AU  - Reape KZ
FAU - Hait, Howard
AU  - Hait H
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - J Fam Pract
JT  - The Journal of family practice
JID - 7502590
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 0 (Estrogens)
RN  - 0 (Hemoglobins)
RN  - 0 (Lipids)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - 5W7SIA7YZW (Levonorgestrel)
SB  - IM
MH  - Adult
MH  - Contraceptives, Oral, Combined/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Estrogens/*administration & dosage/adverse effects
MH  - Ethinyl Estradiol/*administration & dosage/adverse effects
MH  - Female
MH  - Hemoglobins/analysis
MH  - Humans
MH  - Levonorgestrel/*administration & dosage/adverse effects
MH  - Lipids/blood
MH  - Medication Adherence
MH  - Menstruation/drug effects
EDAT- 2010/06/15 06:00
MHDA- 2010/07/16 06:00
CRDT- 2010/06/15 06:00
PHST- 2010/06/15 06:00 [entrez]
PHST- 2010/06/15 06:00 [pubmed]
PHST- 2010/07/16 06:00 [medline]
AID - jfp_5905o [pii]
PST - ppublish
SO  - J Fam Pract. 2010 May;59(5):E3.