Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00005

2 Trial Registration Date

2005-11-14

i Registration Status

Retrospective

3 Secondary IDs

N/A

4 Source(s) of Funding

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

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Prof. Tam Wing Hung

ii Address

1E,Department of O&G, Prince of Wales Hospital, Shatin, N.T., Hong Kong

iii Phone

852 2632 2802

iv Email

tamwh@cuhk.edu.hk

v Affiliation

Associate Professor

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Tam Wing Hung

ii Address

1E,Department of O&G, Prince of Wales Hospital, Shatin, N.T., Hong Kong

iii Phone

852 2632 2802

iv Email

tamwh@cuhk.edu.hk

v Affiliation

Associate Professor

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-04-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Polycystic Ovarian Syndrome

15 Intervention

i Types of intervention

Other

Please specify

Rosiglitazone

ii Description/ name of Intervention/article

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

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo 1 tab B.D.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

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

iii Age Minimum

N/A

iv Age Maximum

N/A

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-11-18

21 Target Sample Size

70

22 Recruitment Status

Complete

23 Primary Outcome

Menstrual status; hirsutism score, free testosterone, SHBG level

24 Secondary Outcome

IMT (Intima Madia Thickness)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-12-04

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2009-12-04