Abstract |
A statistically designed study was carried out to determine an optimum combination of norgestimate and ethinyl estradiol as an oral contraceptive, based on efficacy, safety, and side-effect patterns. A total of 1,991 patients were studied for more than two years while they were receiving various dosage combinations of these steroids. There were seven dosage combinations studied as part of a statistically orthogonal experimental design, augmented by three combinations near the center. The data arising from these studies were used to fit approximate functions relating the amount of norgestimate and ethinyl estradiol to the rate of spotting and breakthrough bleeding, gastrointestinal disturbance, and pregnancies. These functions, in turn, helped to identify an optimum dosage (0.125 mg. of norgestimate plus 0.035 mg. of ethinyl estradiol) in the entire range of combinations studied.
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Authors | J S Lawson, S E Yuliano, S A Pasquale, J J Osterman |
Journal | American journal of obstetrics and gynecology
(Am J Obstet Gynecol)
Vol. 134
Issue 3
Pg. 315-20
(Jun 01 1979)
ISSN: 0002-9378 [Print] United States |
PMID | 377968
(Publication Type: Clinical Trial, Comparative Study, Controlled Clinical Trial, Journal Article)
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Chemical References |
- Contraceptives, Oral
- Contraceptives, Oral, Combined
- Contraceptives, Oral, Hormonal
- Norgestrel
- Ethinyl Estradiol
- norgestimate
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Topics |
- Adolescent
- Adult
- Clinical Trials as Topic
- Contraceptives, Oral
(administration & dosage)
- Contraceptives, Oral, Combined
(administration & dosage, adverse effects)
- Contraceptives, Oral, Hormonal
(administration & dosage)
- Double-Blind Method
- Drug Evaluation
- Ethinyl Estradiol
(administration & dosage, adverse effects)
- Female
- Gastrointestinal Diseases
(chemically induced)
- Humans
- Norgestrel
(administration & dosage, adverse effects, analogs & derivatives)
- Pregnancy
- Random Allocation
- Uterine Hemorrhage
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