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Clinical experience with a triphasic oral contraceptive.
Acta Obstetricia Et Gynecologica Scandinavica
|January 1, 1984
Summary
This clinical trial found that a triphasic oral contraceptive with ethinylestradiol and levonorgestrel demonstrated effectiveness and good cycle control. The contraceptive pill showed a low incidence of side effects in women.
Area of Science:
- Reproductive Health
- Pharmacology
- Clinical Trials
Background:
- Combined oral contraceptives (COCs) are widely used for pregnancy prevention.
- Triphasic formulations offer fluctuating hormone levels, potentially improving tolerability.
- Assessing the efficacy and safety of novel contraceptive formulations is crucial.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of a triphasic combined oral contraceptive (COC).
- To assess cycle control and side effect profile compared to existing low-dose monophasic pills.
Main Methods:
- A multicenter clinical trial involving 367 women over 12 months (3,588 cycles).
- Data collection included continuation rates, pregnancy occurrences, reasons for discontinuation, cycle control parameters, and adverse events.
- Blood pressure and thrombophlebitis incidence were monitored.
Main Results:
- A one-year continuation rate of 67% was observed.
- Five pregnancies occurred, classified as patient failures.
- Cycle control was good, comparable to low-dose monophasic COCs, with a low incidence of side effects.
- One case of elevated systolic blood pressure was noted; no thrombophlebitis was reported.
Conclusions:
- The triphasic oral contraceptive is effective for pregnancy prevention.
- It offers favorable cycle control and a low incidence of adverse effects.
- The formulation appears to be a viable option for women seeking hormonal contraception.
Keywords:
Blood PressureClinical ResearchContraceptionContraception ContinuationContraception TerminationContraceptive AgentsContraceptive Agents, FemaleContraceptive Methods--side effectsContraceptive UsageDemographic FactorsDeveloped CountriesEconomic FactorsEthinyl EstradiolEuropeEvaluationFamily PlanningFertilityHormonesLevonorgestrelMenstrual Cycle--changesMenstruationMethod AcceptabilityNorthern EuropeNorwayOral ContraceptivesOral Contraceptives, Combined--side effectsOral Contraceptives, Phasic--side effectsPhysiologyPopulationPopulation DynamicsReproductionReproductive BehaviorReproductive Control AgentsResearch And DevelopmentResearch MethodologyScandinaviaTechnology