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Rationale for a triphasic oral contraceptive.


 Clinical observation on the use of various oral contraceptive (OC) formulations and the normal hormonal cycle formed the basis for development of Ortho-Novum 7/7/7, a triphasic with a constant low dose of 35 mcg ethinyl estradiol for all 21 tablets and a trilevel adjustment in the progestin. The 1st 7 pills contain .5 mg of norethindrone to encourage estrogen-promoted endometrial growth, the next 7 pills contain .75 mg of norethindrone, and increase intended to minimize midcycle breakthrough bleeding, and the final 7 days contain 1 mg of norethindrone to provide greater endometrial support. Clinical studies in the US, Canada, and France have shown that Ortho-Novum 7/7/7 is effective and safe, that it reduces midcycle breakthrough bleeding sometimes seen in patients on biphasic therapy, that side effects occur infrequently, and that metabolic impact is low. The combined study population consisted of 619 normal, healthy, nonpregnant women aged 18-38 years. Mean age of US subjects was 24.8 years and 81% had had a previous pregnancy. 63% of the Canadian and 52% of the French subjects had never been pregnant. 2 additional special studies were conducted in Canada, an endometrial biopsy study of 20 subjects to assess suppression of ovulation and a gonadotropin study of 29 subjects to assess effects on serum progesterone and pituitary gonadotropin levels. The results showed that serum progesterone levels were relatively low throughout the cycle and there were no ovulatory peaks in either follicle stimulating hormone or luteinizing hormone level. Results of the endometrial biopsy study showed that Ortho-Novum 7/7/7 was effective in preventing ovulation in all 20 subjects, as evidenced by the absence of secretory endometrium. There was no evidence of any histopathological change in the endometrium following 6 cycles of Ortho-Novum 7/7/7. The rate of breakthrough bleeding was comparable to that with Ortho-Novum 1/35, despite the 25% lower progestin content. The observed with higher dose OCs. The incidence of on-pill amenorrhea was 1.2%. A slight to minimal reduction in menstrual bleeding was observed, as well as a trend toward reduction in the severity of dysmenorrhea and premenstrual tension. No significant differences in body weight were noticed before, during, or after the study period, and no clinically significant changes in mean systolic or diastolic blood pressure occurred. Incidences of side effects reported by subjects were very low. The efficacy of Ortho-Novum 7/7/7 is comparable to that of higher dose OCs, with a Pearl index of .22 or less.
