A randomised, double-blind, placebo-controlled crossover trial of the effects of metformin therapy on vascular and metabolic risk in young women with polycystic ovary syndrome. - Effects of metformin on vascular function in Polycystic Ovary Syndrome

Phase 1

• Conditions: Polycystic Ovary Syndrome

• Registration Number: EUCTR2005-005470-69-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-27
• Study Completion: 2008-02-07
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. A diagnosis of polycystic ovary syndrome.

This will be based on evidence of androgen excess (clinical symptoms of hyperandrogenism and/or elevated testosterone) with ovulatory dysfunction (fewer than 6 menstrual cycles per year), supported by ovarian ultrasound where available. Congenital adrenal hyperplasia, Cushing’s syndrome, androgen-secreting neoplasms, hyperprolactinaemia and thyroid disease will be excluded by biochemical testing.

2. Patients will be aged between 18 and 30 years.
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

1. Pregnancy or the intention to become pregnant during the course of this trial.
2. Breastfeeding.
3. A history of current or previous use (within 6 months) of oral contraceptives, antidiabetics or antiandrogens.
4. Medical history of diabetes or hypertension.
5. Contraindications to metformin therapy including renal or hepatic impairment.

Study & Design

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