OPTIMISE
Research type
Research Study
Full title
Comparison of ultra-low-dose Oral versus Transdermal Hormone Therapy on coagulation activation and metabolic risk factors for Cardiovascular Disease
IRAS ID
127558
Contact name
John C Stevenson
Contact email
Eudract number
2013-002094-22
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
Currently there are 2 different ways of taking hormone replacement therapy. Taking a tablet by the mouth (orally) or through the skin (transdermally) by using a patch. We know that taking a tablet improves blood sugar and insulin levels and makes them more steady but that tablets increase the small chance of getting a blood clot in the legs or lungs. We know that patches do not make blood sugar or insulin levels more steady but they reduce the chance of getting a blood clot in the legs and lungs. There is a new very low dose tablet available to patients .We want to compare this new tablet medication against a low dose patch to see if the new low dose tablet has the advantage of reducing the chance of developing a blood clot as well as stabilising blood sugar and insulin and also if it helps women’s symptoms at the time of the menopause . We will be comparing the patch to the new pill by monitoring blood clotting factors, blood sugar, insulin and blood fats. We will also be asking patients about their symptoms before they start treatment and after six months of taking either the pill or the patch to see if they have noticed any improvement in their symptoms on either medication .
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0368
Date of REC Opinion
6 Aug 2013
REC opinion
Further Information Favourable Opinion