Biological Variation of Insulin Resistance, Testosterone and Cardiovascular Risk Factors In Women with Polycystic Ovarian Syndrome: modification with Rimonabant compared to Metformin. - Rimonabant and Metformin in PCOS

Phase 1

• Conditions: Patients with Polycystic Ovary Syndrome and body mass index above 30 kg/m2; MedDRA version: 8.1Level: LLTClassification code 10036049Term: Polycystic ovaries

• Registration Number: EUCTR2006-004447-35-GB
• Lead Sponsor: Hull and East Yorkshire Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-18
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

Polycystic ovarian syndrome
BMI greater than 30

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

Patient should not be currently taking any medications
Unwilling for GP to be informed
Diabetic patients
Uncompensated hypothyroidism
Patients not on barrier contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of study is to determine whether Rimonabant is a therapy for the insulin resistance, hyperandrogenism and metabolic syndrome of PCOS<br> <br>;Secondary Objective: 1.Determine if Rimonabant is comparative to Metformin in reducing mean insulin resistance, high androgen levels and cardiovascular risk indices in women with polycystic ovarian syndrome (PCOS). <br>2.Determine if Rimonabant treatment is comparative to Metformin in reducing the fluctuations in biological variation of insulin resistance and high androgen levels in PCOS.;Primary end point(s): The primary objective of study is to determine if Rimonabant is a therapy for the insulin resistance of PCOS,hyperandrogenism of PCOS and metabolic syndrome in PCOS<br>