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Clinical Trial
. 1997:164:63-5.

Clinical experience of a combined oral contraceptive with very low dose ethinyl estradiol

M Akerlund  1
Affiliations
  • PMID: 9225641
Clinical Trial

Clinical experience of a combined oral contraceptive with very low dose ethinyl estradiol

M Akerlund. Acta Obstet Gynecol Scand Suppl. 1997.

Abstract

Background: The risk of thromboembolic events related to the ethinyl estradiol (EE) dose in oral contraceptive (OC) pills has led to a further dose reduction.

Methods: An OC pill with 150 micrograms desogestrel combined with only 20 micrograms EE was compared with a pill containing the same dose of desogestrel but 30 micrograms of EE in a Scandinavian multicentre study with follow-up visits after 3, 6 and 12 months.

Results: In almost 5,000 cycles with each pill the numbers of pregnancies due to method failure with the lower and higher EE dose pills were 0 and 2, respectively. Irregular bleedings were slightly more common with the lower EE dose, but tended to decrease over the year of study. Other side effects were uncommon. Regarding metabolic effects, both pills tended to raise the plasma HDL level and the lower EE dose pill also reduced LDL. Free testosterone was reduced by two-thirds with both pills, showing beneficial effects on acne.

Conclusions: It is concluded that both these pills are reliable and safe, but that many women would accept a slightly greater risk of irregular bleeding with the 20 micrograms EE dose pill in exchange for a reduction in potential risk related to the estrogenic component of OC pills.

PIP: In response to concerns about a possible thromboembolism risk, the ethinyl estradiol dose in oral contraceptives (OCs) has been further decreased. This study compared the effectiveness and metabolic effects of combined OCs containing 150 mcg of desogestrel and either 20 or 30 mcg of ethinyl estradiol. 1000 Swedish women requesting an OC were randomly assigned to receive either the 150/20 or 150/30 formulation, with follow-up visits scheduled 3, 6, and 12 months after OC initiation. The only 2 pregnancies attributable to method failure occurred in the 150/30 group. Although bleeding irregularities were more common in the 150/20 group, this incidence steadily decreased over the 12-month study period. Overall, bleeding irregularities were experienced by 9.9% of the 500 women in the 150/20 group and 6.0% of the 500 in the 150/30 group. The total cholesterol level increased significantly in the 150/30 mcg group but not in the lower-dose group. Low density lipoprotein cholesterol decreased only among 150/20 OC users. Total triglycerides increased more in users of the 30 mcg pill. Both pills reduced free testosterone levels substantially, but to the same extent. The small percentage of women who experience irregular bleeding with the lowest-dose OC are likely to accept this discomfort in exchange for its potentially improved safety profile.

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