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Published on: March 23, 2016
A low-dose triphasic oral contraceptive
Fertility and Sterility
|March 1, 1987
Summary
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.
- 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.
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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