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Synphasic tablets in Canadian practice: a phase-IV multicenter study.

M G Powell1, C Talbot

  • 1Department of Family and Community Medicine, Women's College Hospital, Toronto, Ontario, Canada.

Clinical Therapeutics
|March 1, 1991
PubMed
Summary

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This summary is machine-generated.

This study shows Synphasic, a low-dose oral contraceptive, effectively reduced bleeding and was well-tolerated by women over four cycles. Patient acceptance was high, with minimal side effects reported.

Area of Science:

  • Reproductive Health
  • Pharmacology
  • Clinical Trials

Background:

  • Oral contraceptives (OCs) are widely used for family planning.
  • Evaluating the real-world performance of low-dose formulations is crucial.
  • Postmarketing surveillance provides essential data on OC efficacy and tolerability.

Purpose of the Study:

  • To assess the performance of a low-dose triphasic oral contraceptive, Synphasic.
  • To evaluate intermenstrual bleeding patterns and patient-reported side effects.
  • To determine patient acceptance of Synphasic in a large, diverse population.

Main Methods:

  • Phase-IV, postmarketing, multicenter trial conducted in Canada.
  • Involved 1,326 primary-care physicians and specialists.
Keywords:
Acceptor CharacteristicsAcceptorsAmericasBleedingCanadaClinical ResearchContraceptionContraception Termination--indicationsContraceptive Methods--side effectsContraceptive UsageData CollectionDelivery Of Health CareDeveloped CountriesDiseasesFamily PlanningFamily Planning ProgramsHealthHealth PersonnelIncidenceMeasurementMenstrual CycleMenstruationMethod AcceptabilityMetrorrhagiaNorth AmericaNorthern AmericaOral Contraceptives, Low-dose--side effectsOral Contraceptives--side effectsPhysiciansReproductionResearch MethodologySigns And Symptoms

Related Experiment Videos

  • Data collected from 5,460 women over 19,756 cycles of Synphasic use.

    • Main Results:

    • Intermenstrual bleeding incidence decreased over four cycles.
    • Bleeding rates were 10% (new OC users), 14% (discontinued OC users), and 16% (OC switchers).
    • Low incidence of headache, nausea, weight gain, breast complaints, and acne was reported.

    Conclusions:

    • Synphasic demonstrated good endometrial control.
    • The oral contraceptive showed a high level of patient acceptance.
    • The study supports the efficacy and tolerability of Synphasic in clinical practice.