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A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone...

Update Il y a 4 ans
Reference: EUCTR2005-002125-32

A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a 1-year safety extension

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Extract

To evaluate the safety and efficacy of 2 variations of an extended regimen of the oral contraceptive SH T 00186 D (0.02 mg EE as ß-CDC and 3 mg DRSP) compared to the standard 24 + 4-day regimen of the same oral contraceptive SH T 00186 D Primary efficacy parameter: -Total number of bleeding days during one year -The number of pregnancies occuring under treatment is considered as co- primary variable

Inclusion criteria

  • healthy volunteers requesting oral contraception

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