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A multicenter efficacy and safety study of an oral contraceptive containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol.

Abstract：

:The study reported herein is the primary efficacy and safety study conducted to support U.S. registration of an oral contraceptive containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol. A large multicenter study enrolled 1,221 women at 50 centers in the United Kingdom. A total of 11,656 cycles of exposure was accumulated, corresponding to approximately 879 women-years of use. Contraceptive efficacy was high; no subject conceived as a result of method failure. The product was generally well tolerated with excellent cycle control, causing fewer than 2% of the subjects to discontinue because of bleeding irregularities. The study medication demonstrated no adverse effects on cervical cytology, blood pressure, body weight or laboratory variables, while pre-existing benign breast disease generally improved. The study did not identify any medication-related adverse experiences. This study confirmed that the monophasic oral contraceptive with 150 micrograms desogestrel and 30 micrograms ethinylestradiol is a safe and effective oral contraceptive with excellent cycle control and patient acceptability. :This multicenter efficacy and safety study was conducted to support US registration of an oral contraceptive (OC) containing 150 mcg desogestrel and 30 mcg ethinyl estradiol. A total of 11,656 cycles of exposure were accumulated, corresponding to about 879 women-years of use. The absence of any method failure confirms its high contraceptive efficacy. The product was generally well tolerated with excellent cycle control, causing fewer than 2% of the subjects to discontinue because of bleeding irregularities. The study medication demonstrated no adverse effects on cervical cytology, blood pressure, body weight or laboratory variables, while pre-existing benign breast disease generally improved. Furthermore, the study did not identify any medication-related adverse experiences. In conclusion, a monophasic OC with 150 mcg desogestrel and 30 mcg ethinyl estradiol is a safe and effective OC with excellent cycle control and patient acceptability.

journal_name

Contraception

journal_title

Contraception

authors

Walling M

doi

10.1016/0010-7824(92)90094-a

subject

Has Abstract

pub_date

1992-10-01 00:00:00

pages

313-26

issue

eissn

0010-7824

issn

1879-0518

pii

0010-7824(92)90094-A

journal_volume

pub_type

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A multicenter efficacy and safety study of an oral contraceptive containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol.