Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome

To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01118598

Enrollment

Registered

2010-05-06

Start date

2010-06-30

Completion date

2012-05-31

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Brief summary

Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome (PCOS).

Detailed description

Polycystic ovary syndrome is a common hormone problem in young women and, as a result of it, they can experience irregular periods, reduced fertility, acne and increased body hair. Frequently, increased weight is a feature. Research suggests that they could have a higher risk of diabetes, high cholesterol and cardiovascular disease such as high blood pressure, angina, heart attack and stroke. The fat from the diet is transported from the stomach into the blood and then taken up by the liver, muscles and fat tissues to store or use as an energy source. Delayed removal of fat from the circulation resulting rise of fat after a meal has been known to happen in PCOS. High fats after a meal are a strong risk factor for cardiovascular disease. Niacin has been in clinical use to lower bad cholesterol and to increase good cholesterol for many years. It has been proved to be effective in reducing risks of heart disease in patients with diabetes. However the effect of niacin on reducing cardiovascular risks and reducing fat level after a meal in PCOS has not been studied and this is why we plan to do this research.

Interventions

DRUGtredaptive (nicotinic acid/ laropiprant)

tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks

DRUGplacebo

placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Females aged between 18 - 50 years * Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement

Exclusion criteria

* Pregnancy/trying to conceive/breast feeding * History of cardiovascular, renal, hepatic and active thyroid disease * History of gout * History of alcohol abuse * History of diabetes * History of allergy to nicotinic acid/laropiprant or food * History of bleeding disorders/active peptic ulcers * Patient on antihypertensive medications * Patient on anticoagulants * Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents * History of smoking more than 15 pack year * Unwilling for GP to be informed

Design outcomes

Primary

Measure	Time frame	Description
Reduction in postprandial triglyceride	3 months	Postprandial triglyceride will be measured using meal test.

Secondary

Measure	Time frame	Description
Reduction in high sensitivity C-reactive protein (CRP)	3 months	—
Improvement in peripheral arterial tone (PAT- index)	3 months	Peripheral arterial tone (PAT- index) will be measured using ENDO PAT 2000 before and after intervention

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026