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  • Title: A new ultra-low-dose combination oral contraceptive.
    Author: Woutersz TB.
    Journal: J Reprod Med; 1983 Jan; 28(1 Suppl):81-4. PubMed ID: 6403705.
    Abstract:
    Data were compiled from 17 U.S. sites during a study of levonorgestrel, 0.15 mg, and ethinyl estradiol, 0.03 mg. A total of 1,130 women participated in 11,604 cycles of treatment. Efficacy, cycle characteristics, bleeding irregularities and side effects were studied. Weight and blood pressure means were analyzed with the paired t-test. Subject acceptance of this new combination oral contraceptive was high. Compilation of recent data on 1130 female volunteers from 17 US sites enrolled in a study of a new low dose combination oral contraceptive (OC) containing .15 mg levonorgestrel and .03 mg ethinyl estradiol are reported. All clients had complete histories and physical examinations at entrance and at 6 month intervals during treatment, and about 20% also had blood sugar, blood urea nitrogen, and liver profile determinations. Follow-up evaluation was performed after the 1st and 3rd cycles and every 3 cycles thereafter to determine patterns of pill taking, bleeding episodes, untoward effects, and concomitant medication. Clients ranged in age from 15-40 with mean age of 23.6; 76.1% were white, 11.9% black, 7.5% Hispanic, and 4.4% Oriental. 61.9% were of proven fertility and 92% had regular cycles. 48.1% of the study population had not used female hormones or been pregnant within 60 days of enrollment. A total of 11,064 cycles over a maximum 31 cycles of treatment are reported. Despite 1-6 or more missed pills in 1623, or 14.7% of the cycles, only 3 pregnancies were reported, only 1 presumed to be a method failure, for a use-effectiveness Pearl index of .35/100 women years of usage. Use of the formulation resulted in a mean cycle length of 28.5 days. 92.7% of cycles ranged from 26-30 days, almost equal to pretreatment values. The frequency of light menstrual flows increased. Breakthrough bleeding was reported in 669 cycles, or 6.0%, while spotting occurred in 852 cycles, or 7.7%. Amenorrhea was reported after 194 cycles (1.8%). No reports of post-pill amenorrhea were made. Incidence of side effects was very low. Only acne, breast discomfort, dysmenorrhea, gastrointestinal symptoms, headache, nausea, and vaginal discharge were reported in more than 1.0% of cycles. The pill had essentially no effect on weight or blood pressure, and produced no clinically significant laboratory abnormalities in hematology, urine, blood sugar, blood urea nitrogen, or liver profile determination. A total of 515 subjects (45.6%) discontinued use of the drug for various nonmedical reasons. Another 146 women (12.9%) discontinued use and gave medical reasons; 132, or 11.7%, were commonly reported side effects of OCs such as breakthrough bleeding, headache, and nausea. Clinical trials with the formulation have shown it to be a safe and effective ultra-low dose combined OC agent whose mode of action is primarily gonadotropin suppression and subsequent anovulation.
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