Assessment of effects of COCP preceded by ellaOne or placebo

• Research type

  Research Study

• Full title

  A prospective, randomized, double-blind parallel-arm, placebo-controlled study to assess the effects on ovarian activity of a combined oral contraceptive pill when preceded by the intake of ellaOne® (ulipristal acetate 30 mg) or placebo

• IRAS ID

  100295

• Contact name

  Sharon Cameron

• Sponsor organisation

  Laboratoire HRA Pharma

• Eudract number

  2011-005573-23

• Research summary

  The aim of the study is to determine how many days of additional contraceptive precautions (such as condoms) are required, before a women who starts a COCP after taking the emergency contraceptive pill known as ellaOne©, can rely exclusively on the COCP to provide her with effective contraception. EllaOne© is an emergency contraceptive (EC) that is available throughout Europe, that has been shown in metanalyses to be more effective than the more commonly used oral EC containing levonorgestrel. However, there is theoretical concern that ellaOne© might make hormonal contraception less effective. Currently there is no evidence on which to base clinical guidance for how many days of additional contraceptive precautions (such as condoms) are required if starting a COCP after taking ellaOne©. This study will recruit healthy female volunteers. Women will be randomised to receive either ellaOne© or a placebo. They will take this when an ultrasound of their ovaries shows that they are approaching ovulation. All women will then start the oral contraceptive pill the following day. Women will make regular attendances for ultrasound scans of their ovaries and a blood test of their hormones, in order for us to determine how many days of COCP taking are required for their ovaries to become quiet under the flunce of the COCP, and that they are not at risk of ovulating. In this way we hope to determine how many days of additional contraceptive precautions are likely to be required in 'real-life' if a woman uses ellaone© for EC and then chooses to start a COCP.

• REC name

  Scotland A REC

• REC reference

  12/SS/0033

• Date of REC Opinion

  27 Mar 2012

• REC opinion

  Favourable Opinion