Treatment of Premature Ovarian Failure

• Research type

  Research Study

• Full title

  A prospective open randomised controlled trial of women diagnosed with premature ovarian failure (POF) to investigate the effects of active treatment with HRT (hormone replacement therapy) or COCP (combined oral contraceptive pill), and observation of patients who choose to have no treatment, on bone density, markers of cardiovascular disease, markers of bone metabolism, menopausal symptoms, quality of life, depression score, sexual function and ovarian function over 2 years.

• IRAS ID

  7233

• Contact name

  Janice Rymer

• Sponsor organisation

  (GSTFT) Guy's and St Thomas NHS Foundation Trust

• Eudract number

  2008-002599-86

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Premature ovarian failure (menopause before the age of 45) is a devastating diagnosis not only because it marks the premature end of fertility but also because it can result in menopausal symptoms due to a low oestrogen level. Oestrogen therapy is recommended to protect against loss of bone density and improve menopausal symptoms but the best form of oestrogen replacement is not known. Currently some women are treated with HRT and some with the combined oral contraceptive pill (COCP). There are also some women who do not wish to take hormone replacement. This study aims to address the question of which treatment has the lowest risk: benefit ratio - not forgetting the important issue of quality of life. 66 women will be recruited. They will be able to choose to be in the 'no treatment' or 'active treatment' group. Those who choose active treatment will be assigned to either taking hormone replacement therapy (HRT) or the combined oral contraceptive pill (COCP). This will be decided by a method equivalent to tossing a coin. Patients will not be able to choose which they take, but will be aware of the medication they are taking (i.e. it is an open trial). At the start of the study, women will have a full medical and gynaecological assessment. They will also have a DXA bone scan to look at bone density, an ultrasound to look at ovarian volume and blood tests to look at ovarian function, bone metabolism and cardiovascular markers. These tests will be repeated at 0,6,12 and 24 months. Validated questionnaires to assess menopausal symptoms, sexual function, quality of life and depression score will be completed and repeated at each clinic visit (0,3,6,12,18 and 24 months). The women will be seen in a dedicated Premature Ovarian Failure clinic.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  08/H0804/140

• Date of REC Opinion

  22 Dec 2008

• REC opinion

  Further Information Favourable Opinion