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TO DETERMINE IF CARDIOVASCULAR RISK INDICES INCLUDING POSTPRANDIAL HYPERTRIGLYCERIDAEMIA ARE MODIFIED FAVOURABLY BY NICOTINIC ACID (NIACIN) IN PATIENTS WITH POLYCYSTIC OVARY SYNDROME (PCOS)

Phase 1
Conditions
Polycystic ovary syndrome
Registration Number
EUCTR2009-015729-35-GB
Lead Sponsor
Hull and East Yorkshire Hospitals NHS Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Age 18-50 year
Polycystic ovary syndrome (evidence of anovulation, clinical or biochemical hyperandrogenism, polycystic ovaries on ultrasound scanning which meets the PCOS diagnostic criteria of Rotterdam consensus statement)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy/ who is trying to conceive/Breast Feeding
2)History of cardiovascular, renal, hepatic and active thyroid disease
3)History of Gout
4)History of alcohol abuse
5)History of Diabetes
6)History of bleeding disorders/ active peptic ulcers
7)Patient on antihypertensive medications
8)Patient on anticoagulants
9)History of allergy to nicotinic acid/ laropiprant/food
10)Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents
11) History of smoking more than 15 pack year
12)Unwilling for GP to be informed

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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