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A low-dose triphasic oral contraceptive.

T B Woutersz, A J Butler, M Cohen

    Fertility and Sterility
    |March 1, 1987
    PubMed
    Summary

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    This summary is machine-generated.

    This study found that a new triphasic oral contraceptive containing levonorgestrel and ethinyl estradiol is highly effective and well-tolerated. It offers excellent cycle control with minimal side effects for women using this birth control method.

    Area of Science:

    • Reproductive Health
    • Pharmacology
    • Clinical Trials

    Background:

    • Oral contraceptives are widely used for family planning.
    • Development of novel contraceptive formulations aims to improve efficacy and tolerability.
    • Triphasic formulations offer a potential advantage in hormone delivery.

    Purpose of the Study:

    • To evaluate the efficacy and safety of a novel three-phase, low-dose oral contraceptive combination.
    • To assess cycle control, side effect profile, and metabolic impact of the new formulation.
    • To determine the use-effectiveness of the oral contraceptive with a day 1 start.

    Main Methods:

    • Controlled clinical investigations conducted across 77 sites (17 US, 60 UK).
    • Involved 3546 female volunteers over 35,036 cycles.
    Keywords:
    BiologyCarbohydrate Metabolic Effects--analysisContraceptionContraceptive AgentsContraceptive Agents, EstrogenContraceptive Agents, FemaleContraceptive Agents, ProgestinContraceptive MethodsContraceptive Methods--side effectsDemographic FactorsDiseasesEndocrine SystemEthinyl EstradiolEvaluationExaminations And DiagnosesFamily PlanningFertility MeasurementsHormonesIncidenceLaboratory Examinations And DiagnosesLevonorgestrelLipid Metabolic Effects--analysisLipidsMeasurementMetabolic EffectsOral ContraceptivesOral Contraceptives, Low-dose--side effectsParityPhysiologyPopulationPopulation CharacteristicsPregnancy RateReproductive Control AgentsResearch Methodology

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  • Utilized a day 1 start in cycle one with no backup contraception.

    • Main Results:

    • Reported nine pregnancies, yielding an uncorrected use-effectiveness rate of 0.33 per 100 woman-years.
    • Demonstrated excellent cycle control with minimal bleeding irregularities.
    • Observed a very low incidence of side effects and no clinically significant variations in blood pressure or weight.

    Conclusions:

    • The triphasic oral contraceptive is an effective and predictable method of contraception.
    • The combination of levonorgestrel and ethinyl estradiol in varying ratios is well-tolerated.
    • This formulation represents a favorable option for women seeking reliable birth control.