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.

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  • Author(s): Poindexter AN;Poindexter AN; Burkman R; Fisher AC; LaGuardia KD
  • Source:
    International journal of fertility and women's medicine [Int J Fertil Womens Med] 2003 Jul-Aug; Vol. 48 (4), pp. 163-72.
  • Publication Type:
    Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: Medical Science Pub. International Country of Publication: United States NLM ID: 9706778 Publication Model: Print Cited Medium: Print ISSN: 1534-892X (Print) Linking ISSN: 1534892X NLM ISO Abbreviation: Int J Fertil Womens Med Subsets: MEDLINE
    • Publication Information:
      Original Publication: Port Washington, NY : Medical Science Pub. International, c1997-
    • Subject Terms:
      Patient Satisfaction*; Contraceptives, Oral, Combined/*administration & dosage ; Estrogens/*administration & dosage ; Ethinyl Estradiol/*administration & dosage ; Norethindrone/*administration & dosage ; Norgestrel/*administration & dosage ; Norgestrel/*analogs & derivatives; Adolescent ; Adult ; Contraceptives, Oral, Combined/adverse effects ; Dose-Response Relationship, Drug ; Drug Combinations ; Estrogens/adverse effects ; Ethinyl Estradiol/adverse effects ; Female ; Humans ; Menstrual Cycle/drug effects ; Middle Aged ; Norethindrone/adverse effects ; Norgestrel/adverse effects ; Surveys and Questionnaires ; Treatment Outcome ; Uterine Hemorrhage/etiology
    • Abstract:
      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.
    • Accession Number:
      0 (Contraceptives, Oral, Combined)
      0 (Drug Combinations)
      0 (Estrogens)
      0 (norgestimate, ethinyl estradiol drug combination)
      37270-71-6 (norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination)
      3J8Q1747Z2 (Norgestrel)
      423D2T571U (Ethinyl Estradiol)
      T18F433X4S (Norethindrone)
    • Publication Date:
      Date Created: 20030919 Date Completed: 20040205 Latest Revision: 20191210
    • Publication Date:
      20250114
    • Accession Number:
      13677549