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

iRegistration Status

Retrospective

3 Secondary IDs

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

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

i Name

Prof. Tam Wing Hung

ii Address

iii Phone

tamwh@cuhk.edu.hk

iv Email

Email

v Affiliation

vi Country

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

i Name

Prof. Tam Wing Hung

ii Address

iii Phone

tamwh@cuhk.edu.hk

iv Email

Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13Research 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

15Intervention

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

16Comparative 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

17Key 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 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

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study 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)

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last 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

None

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Trial History Detail on 2008-05-07