A randomised controlled trial to compare the effect of micronized progesterone and Medroxyprogesterone Acetate on the vascular elasticity, lipid profile and coagulation cascade of women with premature ovarian failure. - Effect of progestogens on cardiovascular health in women with POF (01)

King's College Hospital NHS Foundation Trust0 个研究点目标入组 68 人开始时间: 2012年11月27日最近更新: 2019年6月30日

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•1. Females aged between 16 and up to 45 years.
•2. Confirmed diagnosis of POF with a history of oligomenorrhoea/amenorrhoea for at least 6 months and elevated gonadotrophins = 30mlU/ml on two separate occasions.
•3. Willingness to participate.
•4. No concomitant co-morbidities that would contraindicate the use of hormonal preparations such as unexplained bleeding, breast cancer, endometrial cancer or thromboembolic disease.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 90
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Age under 16 or over 45 years.
•2.Pregnant or lactating females.
•3.Contraindication to the use of hormonal preparations, such as a history of cerebrovascular disease and thromboembolic disease.
•4.Factors present in the past medical history that would contribute to the increased risk of cardiovascular disease, such as, previous myocardial infarction, angina, diabetes, kidney disease, hyperlipidaemia or hypertension.
•5.Personal history of thromboembolic episode or known thrombophilia that would impact on the results of the thrombogenic profile.
•6.Presence of any other clinically significant medical condition, as determined by the investigators.
•7.Known Porphyria.
•8.Known liver disease.
•9.Known past or suspected breast cancer.
•10.Undiagnosed vaginal bleeding.
•11.Genital tract carcinoma.
•12.Thrombophlebitis.
•13.Smokers.
•14.Body mass index >35.
•15.Known hypertensive disease.
•16.Women on concomitant medications that could influence the results, such as anti-hypertensives or anticoagulants.
•17.Known intolerance, allergy or contraindication to the use of oestrogen and/or progesterone.
•18.Known hypersensitivity to the active substances or excipients contained within the utrogestan, Medroxyprogesterone Acetate or Evorel patches
•19.Known allergy to peanuts or soya.

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