NET Vs MPA on thrombin generation
Research type
Research Study
Full title
A pilot randomised controlled trial, to compare the effects of norethisterone acetate and medroxyprogesterone acetate on thrombin generation, vascular elasticity, lipid profiles, and coagulation cascade of women with abnormal uterine bleeding.
IRAS ID
234462
Contact name
Haitham Hamoda
Contact email
Sponsor organisation
The R&D Office, King’s College Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
We are evaluating the effects of norethisterone acetate and medroxy progesterone acetate tablets on the coagulation cascade, vascular elasticity, and lipid profiles in women with abnormal menstrual bleeding. We are not studying the intervention used and purely evaluating the effects or changes it may have on the coagulation cascade, on vascular elasticity, and lipid profiles (parameters which indicate likelihood blood clotting and cardiovascular system (heart system) health. This is important in determining, which, if any medication is more suitable to certain population groups i.e. groups with blood clotting tendency may benefit from medication with less negative effects of blood clotting.
Any patients self reporting abnormal uterine bleeding, between 18 and 51 years of age, without concomitant co-morbidities such as unexplained breast cancer, endometrial cancer or personal history of blood clots to the lungs or legs.
The medications that women taking part in the trial will receive are standard interventions that are used in day to day practice and this group of women will receive them whether they are taking part in the study or not i.e these women would be treated for abnormal uterine bleeding with these tablets .
The additional part of taking part in the study will involve providing a blood sample to assess coagulation and lipid effects and assessment of pulse wave velocity through an external device placed on the patient’s arm.
The study will take place at King's College Hospital in Camberwell, gynaecology outpatients department. There will be 2 visits at monthly intervals; both of which, the patients will undergo the above blood taking procedures.
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0730
Date of REC Opinion
17 May 2018
REC opinion
Further Information Favourable Opinion