§ Mr. SwayneTo ask the Secretary of State for Health if Levonorgestrel is licensed for use by girls between the ages of 11 and 15. [147133]
§ Ms StuartLevonorgestrel is available as a prescription-only medicine, without an age limit. It may therefore be prescribed to women aged under 16 years. When given for the purposes of emergency contraception, prescribers are expected to satisfy themselves, in accordance with guidelines, that the young person understands the advice and it is in their best interests to receive the treatment. From 1 January 2001, pharmacists have been permitted to supply Levonorgestrel 0.75 mg to women aged 16 years and over for use as an emergency contraceptive.
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§ Mr. SwayneTo ask the Secretary of State for Health what clinical trials involving girls between the ages of 11 and 15 years have been conducted with respect to Levonorgestrel. [147134]
§ Ms StuartNo clinical trials specific to this age group have been undertaken in the United Kingdom. The marketing authorisation granted in 1999 for Levonorgestrel 0.75 mg tablets as a prescription-only medicine was supported by evidence from two large randomised controlled studies, one conducted by the World Health Organisation, and published data from uncontrolled studies. Most women in the clinical trials were aged between 16 and 48, but a few girls aged 14 and 15 were included. There were no data available for girls between aged 11 and 14 years. Age analysis of efficacy and safety in the randomised studies did not identify any population that responded differently to treatment.