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A new ultra-low-dose combination oral contraceptive
The Journal of Reproductive Medicine
|January 1, 1983
Summary
This study shows that a new oral contraceptive containing levonorgestrel and ethinyl estradiol is highly accepted by women. It was found to be effective with acceptable cycle characteristics and side effects.
Area of Science:
- Reproductive Health
- Pharmacology
- Clinical Trials
Background:
- Oral contraceptives are widely used for pregnancy prevention.
- New formulations are continuously developed to improve efficacy and user experience.
Purpose of the Study:
- To evaluate the efficacy, cycle characteristics, bleeding patterns, and side effects of a new combination oral contraceptive.
- To assess subject acceptance of the new oral contraceptive formulation.
Main Methods:
- A multicenter study involving 1,130 women across 17 U.S. sites.
- Data collected over 11,604 treatment cycles.
- Analysis of efficacy, cycle characteristics, bleeding irregularities, side effects, weight, and blood pressure using paired t-test.
Main Results:
- The combination oral contraceptive demonstrated high subject acceptance.
- Efficacy, cycle characteristics, bleeding patterns, and side effects were assessed.
- No significant adverse effects on weight or blood pressure were noted.
Conclusions:
- The new oral contraceptive containing levonorgestrel (0.15 mg) and ethinyl estradiol (0.03 mg) is well-tolerated and highly accepted by users.
- The formulation appears to be a viable option for women seeking reliable contraception.
Keywords:
Acceptor CharacteristicsAcceptorsContraceptionContraception TerminationContraceptive AgentsContraceptive Agents, FemaleContraceptive Methods--pharmacodynamicsContraceptive Methods--side effectsFamily PlanningFamily Planning ProgramsMenstrual CycleMenstruationOral Contraceptives, CombinedOral Contraceptives, Low-doseOral Contraceptives--pharmacodynamicsOral Contraceptives--side effectsReproductionReproductive Control Agents