PMID- 13677549
OWN - NLM
STAT- MEDLINE
DCOM- 20040205
LR  - 20191210
IS  - 1534-892X (Print)
IS  - 1534-892X (Linking)
VI  - 48
IP  - 4
DP  - 2003 Jul-Aug
TI  - Cycle control, tolerability, and satisfaction among women switching from 30-35 
      microg ethinyl estradiol-containing oral contraceptives to the triphasic 
      norgestimate/25 microg ethinyl estradiol-containing oral contraceptive Ortho 
      Tri-Cyclen LO.
PG  - 163-72
AB  - OBJECTIVE: To determine cycle control, tolerability, and satisfaction among women 
      (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 microg 
      ethinyl estradiol (EE) to Ortho Tri-Cyclen LO (norgestimate 180/215/250 microg/EE 
      25 microg) and Loestrin Fe 1/20 (norethindrone acetate 1 mg/EE 20 microg). 
      DESIGN: A subset of patients from a study comparing Ortho Tri-Cyclen LO (N = 864) 
      with Loestrin Fe 1/20 (N = 565) was analyzed. The subset was defined as those who 
      had taken a 30-35 microg EE-containing OC within 60 days of study start. The 
      total number of cycles of exposure for the subset was 6,054 for Ortho Tri-Cyclen 
      LO and 3,814 for Loestrin Fe 1/20. Additional analyses evaluated switchovers from 
      Ortho Tri-Cyclen to Ortho Tri-Cyclen LO (N = 111). MAIN OUTCOME MEASURES: Cycle 
      control was assessed by daily diary cards reporting the frequency, severity, and 
      duration of bleeding/spotting. Discontinuation rates due to adverse events (AEs) 
      were considered to reflect tolerability. Satisfaction was evaluated by 
      questionnaire. RESULTS: The proportion of cycles in which subjects experienced 
      breakthrough bleeding and/or spotting was significantly lower with Ortho 
      Tri-Cyclen LO than Loestrin Fe 1/20. Discontinuations due to AEs and serious AEs 
      were comparable for Ortho Tri-Cyclen LO (3.4% and 0.6%, respectively) and 
      Loestrin Fe 1/20 (3.2% and 0.7%, respectively). More women on Ortho Tri-Cyclen LO 
      versus Loestrin Fe 1/20 were very or somewhat satisfied at Cycle 6 (86% vs. 
      81.1%; P < 0.05) and last visit (81.6% vs. 78.1%; P < 0.05). At Cycle 6, 89.3% of 
      Ortho Tri-Cyclen to Ortho Tri-Cyclen LO switchovers were very or somewhat 
      satisfied, and 72.6% desired to continue taking Ortho Tri-Cyclen LO after study 
      conclusion. Conclusions-Switchovers from OCs containing 30-35 microg EE to Ortho 
      Tri-Cyclen LO had excellent cycle control and tolerability, and were satisfied.
FAU - Poindexter, Alfred N
AU  - Poindexter AN
AD  - Baylor College of Medicine Houston, Texas, USA.
FAU - Burkman, Ronald
AU  - Burkman R
FAU - Fisher, Alan C
AU  - Fisher AC
FAU - LaGuardia, Katherine D
AU  - LaGuardia KD
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Int J Fertil Womens Med
JT  - International journal of fertility and women's medicine
JID - 9706778
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 0 (Drug Combinations)
RN  - 0 (Estrogens)
RN  - 0 (norgestimate, ethinyl estradiol drug combination)
RN  - 37270-71-6 (norethindrone acetate, ethinyl estradiol, ferrous fumarate drug 
      combination)
RN  - 3J8Q1747Z2 (Norgestrel)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - T18F433X4S (Norethindrone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Contraceptives, Oral, Combined/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Drug Combinations
MH  - Estrogens/*administration & dosage/adverse effects
MH  - Ethinyl Estradiol/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Menstrual Cycle/drug effects
MH  - Middle Aged
MH  - Norethindrone/*administration & dosage/adverse effects
MH  - Norgestrel/*administration & dosage/adverse effects/*analogs & derivatives
MH  - *Patient Satisfaction
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Uterine Hemorrhage/etiology
EDAT- 2003/09/19 05:00
MHDA- 2004/02/06 05:00
CRDT- 2003/09/19 05:00
PHST- 2003/09/19 05:00 [pubmed]
PHST- 2004/02/06 05:00 [medline]
PHST- 2003/09/19 05:00 [entrez]
PST - ppublish
SO  - Int J Fertil Womens Med. 2003 Jul-Aug;48(4):163-72.