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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118598
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : July 15, 2019
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

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).

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: tredaptive (nicotinic acid/ laropiprant) Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)
Study Start Date : June 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: placebo arm
this group will receive placebo as per protocol
Drug: placebo
placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks

Active Comparator: tredaptive
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Drug: tredaptive (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
Other Name: tredaptive

Primary Outcome Measures :
  1. Reduction in postprandial triglyceride [ Time Frame: 3 months ]
    Postprandial triglyceride will be measured using meal test.

Secondary Outcome Measures :
  1. Reduction in high sensitivity C-reactive protein (CRP) [ Time Frame: 3 months ]
  2. Improvement in peripheral arterial tone (PAT- index) [ Time Frame: 3 months ]
    Peripheral arterial tone (PAT- index) will be measured using ENDO PAT 2000 before and after intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118598

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United Kingdom
Hull & East Yorkshire Hospitals NHS Trust
Hull, United Kingdom, HU3 2RW
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
Merck Sharp & Dohme LLC
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Principal Investigator: Stephen L Atkin, FRCP, PhD University of Hull
Additional Information:
Publications of Results:
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Responsible Party: Hull University Teaching Hospitals NHS Trust Identifier: NCT01118598    
Other Study ID Numbers: R0920 PCOS & Niacin
ISRCTN37787683 ( Registry Identifier: ISRCTN )
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Keywords provided by Hull University Teaching Hospitals NHS Trust:
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Nicotinic Acids
Vitamin B Complex
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents