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Indications & Dosage
INDICATIONS AND USAGE
ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females, 15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Text Continues Below
In clinical trials with ORTHO-CYCLEN, 1,651 subjects completed 24,272 cycles and a total of 18 pregnan-cies were reported. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 0.96 per 100 women-years. This rate includes patients who did not take the drug correctly. In four clinical trials with ORTHO TRI-CYCLEN, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on ORTHO TRI-CYCLEN, 8 pregnancies were reported. This represents an overall use-efficacy preg-nancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, ORTHO TRI-CYCLEN showed a statistically significant decrease in inflammatory lesion count and total lesion count (Table II). The adverse reaction profile of ORTHO TRI-CYCLEN from these two controlled clinical trials is consistent with what has been noted from previous studies involving ORTHO TRI-CYCLEN and are the known risks associated with oral contraceptives. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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