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Trial History Detail on 2009-11-19

CUHK_CCT00005

2005-11-14

Retrospective

1) Lee Hysan Foundation Research Grant and Endowment Fund Research Grant 2003/2004 (United College, CUHK) 2) RGC Research Grant Direct Allocation 2004 (CUHK)

N/A

N/A

Prof. Tam Wing Hung

Email tamwh@cuhk.edu.hk

Prof. Tam Wing Hung

Email tamwh@cuhk.edu.hk

Clinical and Metabolic Effects of Rosiglitazone on Women with Polycystic Ovarian Syndrome

Yes

2004-04-20

Polycystic Ovarian Syndrome

Other

Rosiglitazone

Rosiglitazone 4mg B.D. (8mg per day)

12 months

Placebo 1 tab B.D.

INCLUSION CRITERIA: (At least 2 of the major criteria listed below) Major criteria: 1) Anovulation (with other causes of anovulation excluded); 2) Clinical signs of hyperandrogenism (hirsutism or acne) and/or hyperandrogenemia (with other causes of hyperandrogenemia excluded); Minor criteria: 1) Elevated early follicular phase (LH >10 IU/L); 2) Elevated LH/FSH ratio (>2.5); 3) Polycystic ovaries on ultrasound scan 4) Obesity (BMI > 25) / Insulin resistance

EXCLUSION CRITERIA: 1) Women with PCOS who are planning for pregnancy, or undergoing fertility treatment; 2) Women with PCOS who are already on oral hypoglycaemic agents or insulin treatment; 3) Women with cardiovascular disease, hepatic or renal function impairment; 4) Women on corticosteroid therapy; 5) Women with known endometrial hyperplasia

Randomized

Placebo

Double-blind

Parallel

2004-11-18

70

Complete

Menstrual status; hirsutism score, free testosterone, SHBG level

IMT (Intima Madia Thickness)

No

2009-12-04


Yes

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