Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00136

2 Trial Registration Date

2007-08-14

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

Department of Obstetrics & Gynaecology, The Chinese University of Hong Kong

5 Primary Sponsor

nil

6 Secondary Sponsor

nil

Function

Please specify

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

i Name

Dr Chan Shing Chee, Symphorosa

ii Address

iii Phone

Dept of O&G, PWH

iv Email

Tel: 2632 2583, email: symphorosa@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Dr Chan Shing Chee, Symphorosa

ii Address

iii Phone

Dept of O&G, PWH

iv Email

Tel: 2632 2583, email: symphorosa@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

A Randomized, Crossover Study of Medroxyprogesterone Acetate and Diane-35 on Polycystic Ovarian Syndrome Adolescents

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

A Randomized, Crossover Study of MPA and Diane-35 on PCOS Adolescents

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-05-04

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

Drug

Please specify

ii Description/ name of Intervention/article

Group 1 will receive oral (medroxyprogesterone acetate) MPA 10 mg daily for 10 days for every month for the first 4 months, followed by a washout period of 4 months, and then diane-35 one tablet daily for 21 days for every month for another 4 months. Group 2 will receive the same combination but in reverse order.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 months treatment, 4 months washout & 4 months treatment

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Group 1 will receive oral (medroxyprogesterone acetate) MPA 10 mg daily for 10 days for every month for the first 4 months, followed by a washout period of 4 months, and then diane-35 one tablet daily for 21 days for every month for another 4 months. Group 2 will receive the same combination but in reverse order.

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: Patients aged 14 to 19 and diagnosed PCOS in the Gynaecology clinics of AHNH and PWH. The diagnosis of PCOS is based on the Rotterdam consensus on diagnostic criteria for PCOS; that is, at least 2 out of 3 of the following criteria: 1) Oligo- and / or anovulation; 2) Clinical and / or biochemical signs of hyperandrogenism; 3) Ultrasound appearance of polycystic ovaries; and exclusion of other aetiologies. Exclusion criteria are: 1) patient who has fertility wish; 2) confirmed concomitant diabetics mellitus which may need other medical treatment for PCOS; 3) significant liver impairment or other medical condition that is contraindicated for MPA or diane-35; and 4) previous use of hormonal treatment in the past 4 months.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Crossover

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2007-08-22

21 Target Sample Size

100

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The primary outcome measure is the psychological well being of the subjects on the different treatments, using a standard questionnaire 36-item Short Form Health Survey (SF-36) and a client satisfaction questionnaire. They will be assessed during every visit (ie at baseline, 4 month, 8 month & 12 month of study)

24 Secondary Outcome

All of the following will be assessed or measured during every visit (ie at baseline, 4 month, 8 month & 12 month of study) 1. Menstrual pattern and any abnormal bleeding throughout the study period. 2. Clinical parameters including body mass index, blood pressure, waist-to-hip circumference ratio, scoring on acne and hirsutism. 3. Hormonal profile by measurements of serum concentrations of luteinizing hormone, follicular stimulating hormone, oestradiol, testosterone, sex hormone binding globulin, and androstenedione.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-03-03

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 2007-08-14