Clinical study of a new, normophasic type oral contraceptive
Dombrowicz, N.
Bruxelles Medical 53(12): 747-755
1973
ISSN/ISBN: 0068-3027 PMID: 4778356 Document Number: 64365
A new "normophasic" oral contraceptive, Fisioquens (7 tablets of .05 mg ethinylestradiol, and 15 tablets with .05 mg ethinylestradiol and 1 mg lynestrenol) was taken by 120 fertile women for an average of 9.24 cycles, maximum of 12 cycles, and a total of 1108 cycles. There were no pregnancies, no drug related drop outs, good menstrual control and very few side effects. Latent period before withdrawal bleeding was 2-3 days in 89.9% of cycles. Bleeding lasted 4.5 days in 72% of cycles, occurred every 28 days in 88%, was usually the same in amount, sometimes increased. There was breakthrough bleeding in .38% of cycles, spotting in 2%, and amenorrhea in only 2 cycles. Side effects included nausea (worsened in 3.3%, improved in 5%); headache (worsened in 9.1%, improved in 10.8%); breast pain (worsened in 7.5%, improved in 17.5%); leg pain (worsened in 8.3%, improved in 7.5%); leucorrhea (worsened in 1.6%, improved in 30.8%); psychological status (worsened in 2.4%, improved in 7.5%). Whether the patients had previously been taking other pills was not stated. The author concluded that this formulation was efficacious and acceptable because it resembles a sequential, but gives longer protection of progestagen.