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Clinical Trial
. 2007 Sep;12(3):220-8.
doi: 10.1080/13625180701440818.

A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 microg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight

Jan Endrikat  1 , Mirella Sandri, Christoph Gerlinger, Alexander Rübig, Werner Schmidt, Michel Fortier
Affiliations
Clinical Trial

A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 microg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight

Jan Endrikat et al. Eur J Contracept Reprod Health Care. 2007 Sep.

Abstract

Objectives: To evaluate the effects of an oral contraceptive containing 3 mg drospirenone (DRSP) and 30 microg ethinyl oestradiol (EE) on somatic and psychological symptoms related to water retention, and on body weight.

Methods: This prospective study was performed in 26 centres in Canada over six treatment cycles. The first primary efficacy variable was the individual change in the water retention score of the Moos Menstrual Distress Questionnaire (MDQ) from baseline to the final examination in women with significant somatic symptoms related to water retention (n = 43). The second primary target variable was the change in body weight (n = 305).

Results: Forty-three women met the criteria for the first primary target variable. In the premenstrual phase, the score decreased from 6.49 (SEM 0.45) at baseline to 3.19 (SEM 0.54) at the final examination (p = 0.0001). The data for the menstrual phase were 4.70 (SEM 0.30) at baseline and 2.35 (SEM 0.32) at the final examination (p < 0.0001). Baseline data from 299 women were assessed for the second primary target variable. Body weight did not change significantly, having increased only by 0.14 kg (SEM 0.13) at the final visit (p = 0.3082).

Conclusion: An oral contraceptive containing 3 mg DRSP and 30 microg EE significantly reduced the clinical symptoms of water retention. Body weight did not change.

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