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Multicenter trial of a monophasic oral contraceptive containing ethinyl estradiol and desogestrel.

Abstract：

:A clinical trial was conducted at 47 centers in 11 countries to assess the efficacy and acceptability of a monophasic oral contraceptive containing 30 micrograms ethinyl estradiol and 150 micrograms desogestrel. 1,613 women took part for a total of 23,258 cycles. One pregnancy occurred in a cycle where two consecutive tablets had been forgotten. Cycle control was excellent, with reported decreases in the duration and amount of withdrawal bleeding during consecutive treatment cycles and a low incidence of irregular bleeding. Blood pressure was not affected during 2 years of use. The incidence of minor side effects was already low in the first treatment cycle and decreased further in the subsequent cycles. The combination (Marvelon) was shown to be a very reliable and acceptable oral contraceptive. :The efficacy and acceptability of a monophasic oral contraceptive (OC) containing 30 mcg of ethinyl estradiol and 150 mcg of desogestrel were evaluated in a clinical trial involving 1613 women at 47 centers in 11 countries. A total of 23,258 menstrual cycles were available for analysis. Although or more tablets were forgotten in 892 cycles (3.8%), there was only 1 pregnancy due to patient failure in this study and no pregnancies attributable to method failure. Cycle control was good and comparable to that reported for other low-dose OCs. In 90% of the cycles, the withdrawal bleed started 1-4 days after intake of the last pill and lasted 5 days or less. The incidence of breakthrough bleeding and spotting decreased with duration of pill use. After 24 cycles, the discontinuation rate because of bleeding problems was only 6%. The discontinuation rate for minor side effects was 4% after 24 cycles; these side effects included nausea, headache, nervousness, and breast tension. After 24 cycles, body weight was not affected in 70% of the participating women, 18% reported a weight increase of greater than 2 kg, and 12% experienced a weight decrease of over 2 kg. Most of the women who reported a weight gain were under 20 years of age. The ethinyl estradiol-desogestrel combination had no effect on average blood pressure. Previous research has shown desogestrel to have unique advantages as the progestogen component of combined OCs in that it does not counteract the ethinyl estradiol-induced increase in high-density lipoprotein. This, together with the good reliability and acceptability recorded in the present study, suggests that the monophasic desogestrel OC should be prescribed on a widespread basis.

journal_name

Acta Obstet Gynecol Scand

journal_title

Acta obstetricia et gynecologica Scandinavica

authors

Rekers H

doi

10.3109/00016348809004193

subject

Has Abstract

pub_date

1988-01-01 00:00:00

pages

171-4

issue

eissn

0001-6349

issn

1600-0412

journal_volume

pub_type

临床试验,杂志文章

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Multicenter trial of a monophasic oral contraceptive containing ethinyl estradiol and desogestrel.