Patients with Polycystic Ovary Syndrome and body mass index above 30 kg/m2 MedDRA version: 8.1 Level: LLT Classification code 10036049 Term: Polycystic ovaries
Conditions
Interventions
Trade Name: Glucophage
Product Name: Metformin
Pharmaceutical Form: Tablet
INN or Proposed INN: glucophage
CAS Number: 657-24-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Hull and East Yorkshire Hospital Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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). 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 | — |
Countries
United Kingdom
Outcome results
None listed