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A randomized double blind study of two oral contraceptives
Contraception
|July 1, 1979
Summary
This study compared Ovral and Norinyl oral contraceptives in family planning programs. Both brands had similar side effects, with country influencing outcomes more than the pill brand.
Area of Science:
- Reproductive Health
- Contraception
- Public Health
Background:
- Oral contraceptives are crucial for family planning programs.
- Assessing the comparative acceptability of different oral contraceptive brands is essential for program effectiveness.
- Publicly-assisted programs require cost-effective and well-tolerated contraceptive options.
Purpose of the Study:
- To evaluate the comparative acceptability of two oral contraceptive brands, Ovral and Norinyl.
- To determine if differences in side effects or continuation rates exist between Ovral and Norinyl.
- To inform decisions regarding oral contraceptive selection in publicly-assisted family planning programs.
Main Methods:
- A double-blind study involving 1,200 women in Costa Rica and Trinidad.
- Random assignment of either Ovral or Norinyl to participants.
- Monitoring and recording of common side effects and continuation rates.
Main Results:
- Nausea, dizziness, vomiting, and headaches were reported for both Norinyl and Ovral.
- Side effect rates varied more by country than by the oral contraceptive brand used.
- Ovral use in Costa Rica was linked to increased skin issues (chloasma).
- Intermenstrual bleeding and spotting were more frequent with Norinyl in both locations, impacting continuation rates in Costa Rica.
Conclusions:
- Generally, Ovral and Norinyl demonstrate comparable acceptability for family planning programs.
- Country-specific factors significantly influence the occurrence of side effects and continuation rates.
- Minor differences in side effect profiles (e.g., skin issues with Ovral, bleeding with Norinyl) exist but do not appear to broadly impact program use.
Keywords:
AmericasBiologyBleedingCaribbeanCentral AmericaContraceptionContraception ContinuationContraceptive Agents, Estrogen--side effectsContraceptive Agents, Female--side effectsContraceptive Agents, Progestin--side effectsContraceptive Agents--side effectsCosta RicaDermatitisDeveloping CountriesDiseasesDouble-blind StudiesEthinyl Estradiol--side effectsFamily PlanningGastrointestinal EffectsLatin AmericaMelanosisMelasmaMestranol--side effectsMetrorrhagiaNorethynodrel--side effectsNorth AmericaOral ContraceptivesOral Contraceptives, CombinedPhysiologyResearch MethodologySigns And SymptomsStudiesTrinidad And Tobago