Evaluation of d-norgestrel 1.0 mg in cyclic regimen
McQuarrie, H.G.; Harris, J.W.; Ellsworth, H.S.; Stone, R.A.; Anderson, A.E.
Journal of Reproductive Medicine 10(4): 200-202
1973
ISSN/ISBN: 0024-7758 PMID: 4695502 Document Number: 65312
111 women took a total of 584 cycles of 1.0 mg norgestrel for 21 days out of a 28 day cycle, in a trial of a low-dose progestin-only oral contraceptive, intended to avoid the side effects of estrogen and the menstrual irregularity of mini-pills. This study followed an 18 month blind trial of norgestrel, .5, 1.0 and 1.5 mg in 100 patients, which found the 1.0 mg dose most suitable. 33.6% of these subjects had used pills within the last 90 days, and all were private patients of the Western Gynecological and Obstetrical Clinic, Inc. 97.7% of menstrual cycles before, and 81% during the trial were 21-35 days in length; the mean cycle length was 28.8 days before, and 29.0 days during treatment. Menses lasted a mean of 4.8 days before and 5.6 days during norgestrel. Menstrual flow became lighter in most, but breakthrough bleeding increased from 1.8% to 10%, spotting from 6.3% to 30.7%, and amenorrhea from 4.5% to 11.1%. Dropouts included 10 for bleeding, 5 for weight gain, 3 for acne, and 1 each for edema, generalized somatic complaints, irritability, depression and decreased libido. One pregnancy resulted from patient failure. The authors concluded that, except for the "fastidious," most women should not object to this degree of irregular bleeding, once it becomes "individualized."