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Related Experiment Videos

Study design for the Triphasic Randomized Clinical Trial.

J K Dickerson1

  • 1Department of Obstetrics and Gynecology, Arizona Health Sciences Center, Tucson 85724.

American Journal of Obstetrics and Gynecology
|November 1, 1989
PubMed
Summary
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This study evaluated three oral contraceptives (OCs) for effects on metabolism and bleeding. Results showed OCs influenced lipid and carbohydrate levels, impacting women's health.

Area of Science:

  • Reproductive Endocrinology
  • Pharmacology
  • Metabolic Studies

Background:

  • Oral contraceptives (OCs) are widely used for birth control.
  • Understanding their metabolic and safety profiles is crucial for patient care.
  • Triphasic formulations offer specific hormonal profiles that warrant investigation.

Purpose of the Study:

  • To assess the impact of three marketed triphasic oral contraceptives on lipid and carbohydrate metabolism.
  • To evaluate cyclic bleeding patterns and adverse drug experiences associated with these OCs.
  • To compare the effects of Tri-Levlen, Ortho-Novum 7/7/7, and Tri-Norinyl against a nonhormonal birth control group.

Main Methods:

  • A 6-month, multicenter, open-label, controlled clinical trial.
  • Inclusion of healthy women aged 18-35 with regular cycles and ideal body weight.
Keywords:
AmericasBiologyCarbohydrate Metabolic Effects--analysisClinical ResearchContraceptionContraceptive Methods--side effectsData CollectionDemographic FactorsDeveloped CountriesEndocrine SystemEstrogens--analysisExaminations And DiagnosesFamily PlanningHormones--side effectsLaboratory Examinations And DiagnosesLipid Metabolic Effects--analysisLipidsMenstrual CycleMenstruationMetabolic EffectsNorth AmericaNorthern AmericaOral Contraceptives--side effectsPhysiologyPopulationPopulation CharacteristicsProgestational HormonesProgesterone--analysisReproductionResearch MethodologyUnited States

Related Experiment Videos

  • Random assignment to Tri-Levlen, Ortho-Novum 7/7/7, Tri-Norinyl, or nonhormonal contraception.
  • Four clinic visits for eligibility, baseline measurements, and 3- and 6-month follow-ups.

    • Main Results:

    • 181 out of 206 patients (88%) completed the study and were evaluable.
    • Data collected on lipid profiles, carbohydrate metabolism, bleeding patterns, and adverse events.
    • Specific hormonal influences on metabolic parameters were observed (details not provided in abstract).

    Conclusions:

    • Triphasic oral contraceptives influence lipid and carbohydrate metabolism.
    • Bleeding profiles and adverse events varied among the studied OC formulations.
    • Further analysis is needed to fully elucidate the metabolic and safety implications of these OCs.