A multicenter comparative trial of triphasic and monophasic, low-dose combined oral contraceptives

• Published in: Contraception (Stoneham) Vol. 47; no. 6; pp. 515 - 525
• Main Authors: Dunson, Thomas R., McLaurin, Vivian L., Aguayo, Eduardo Leon, de Silva, Priya, Calventi, Vinicio, Gerais, Abdel Salam, Serani, Rene Guzman
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.06.1993; Elsevier Science
• Subjects: Adolescent; Adult; Biological and medical sciences; Birth control; Chile; Contraceptives, Oral, Combined - administration & dosage; Contraceptives, Oral, Combined - adverse effects; Dominican Republic; Ecuador; Ethinyl Estradiol - administration & dosage; Ethinyl Estradiol - adverse effects; Ethinyl Estradiol-Norgestrel Combination; Female; Gynecology. Andrology. Obstetrics; Hormonal contraception; Humans; Levonorgestrel - administration & dosage; Levonorgestrel - adverse effects; Medical sciences; Norgestrel - administration & dosage; Norgestrel - adverse effects; Pregnancy; Sri Lanka; Sudan; Dominican Republic; Ecuador; Chile; Sri Lanka; Sudan; Ethinylestradiol; Human; Low dose; Estrogen; Oral administration; Tolerance; Contraception; Progestagen; Estroprogestagen; Female; Contraceptive; Triphasic contraceptive; Comparative study; Comparative Studies; Headache; Contraceptive Usage; Research Methodology; Clinical Trials; Bleeding; User Compliance; Vertigo; Contraceptive Effectiveness; Metrorrhagia; Oral Contraceptives, Low-dose; Oral Contraceptives, Phasic; Oral Contraceptives, Combined; Clinical Research; Contraceptive Methods; Research Report; Behavior; Oral Contraceptives; Method Acceptability; Family Planning; Diseases; Studies; Signs And Symptoms; Developing Countries; Contraception Continuation
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/0010-7824(93)90020-8

A comparative multicenter clinical trial of two combined oral contraceptives (OCs) was conducted at clinics located in the Sudan, Sri Lanka, Chile, the Dominican Republic and Ecuador. The trial was designed to determine if there were differences in efficacy, safety and acceptability between a triphasic and a low-dose monophasic OC. This report includes analysis of 1088 women. At each center, subjects were randomly allocated to one of the two OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. There were two accidental pregnancies attributed to user failure reported during the study period; one in the triphasic group and one in the monophasic group. Adverse experiences were mainly minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. Cycle control was good in both groups with women in the triphasic group reporting fewer complaints of intermenstrual bleeding. Both OCs were safe and effective.