Efficacy and safety of ethynodiol diacetate 1 mg with ethynylestradiol 35 ug with an emphasis on contraceptive efficacy a phase iv trial
Friedman, A.J.; Wheeler, J.
Journal of Reproductive Medicine 36(4 Suppl): 328-333
1991
ISSN/ISBN: 0024-7758 Document Number: 314858
A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 .mu.g (EDA1 mg with EE 35 .mu.g) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA1 mg with EE 35 .mu.g for one to eight months. Clinical evaluation forms on 6,382 patients were amenable to analysis for safety (including breakthrough bleeding, ovarian cyst formation and complexion changes); 5,412 patients were evaluable for efficiacy (prevention of pregnancy), with a total of 21,440 cycles recorded. The study results were interpreted in terms of the impact on clinical management of oral contraceptive users and the methods, strengths and weaknesses of phase IV trials, particularly as they relate to confirmations of the results reported here.