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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201307000567163 Date registered: 2013/06/18
TRIAL DESCRIPTION
Public title Comparing the effects of metformin versus combined Contraceptive pills in adolescent PCOS
Official scientific title Metformin versus combined oral contraceptives in adolescent PCOS through a 24 months follow up period : a randomized controlled trial
Brief summary describing the background
and objectives of the trial
PCOS has a fetal origin and the phenotype presents as early as adolescence or even before. Early detection and management are important to decrease co morbidity. The current study compares the effect of metformin and oral contraceptive pills on PCOS profile in adolescence
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2010-02-15
Actual trial start date 2010-02-15
Anticipated date of last follow up 2013-10-30
Actual date of last follow up 2013-10-30
Anticipated target sample size (number of participants) 120   
Actual target sample size (number of participants) 120   
Recruitment status Closed to recruitment: follow up continuing
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block method (block size 4, not variable) Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Metformin group 1700 mg 24 weeks 40
Experimental group OCPs ethinyl estradiol and 15 mg progestin 24 weeks 40
Control group Control 40 Uncontrolled

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
hirsutism acne menstrual disturbances. oligomenorrhea (<6 cycles /year) serum testosterone >1 µg/ml Suprarenal dysfunction hyperprolactinaemia thyroid dysfunction or recent intake of medications likely to affect hormonal profile 15 Years 19 Years Female

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2010/02/10 Alexandria IVF/ICSI Center Ethical Committee
Ethics Committee Address
Street address City Postal code Country
4 Mogahedin street el Hedaya Alexandria Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement in fasting serum insulin levels, and Glucose/Insulin ratio 6, 12, 18 and 24 months after start of intervention
Primary Outcome reduction in serum testosterone levels 6, 12, 18 and 24 months after start of intervention
Secondary Outcome improvement in cycle rhythm 6, 12, 18 and 24 months after start of intervention
Secondary Outcome hirsutism 6, 12, 18 and 24 months after start of intervention
Secondary Outcome weight loss 6, 12, 18 and 24 months after start of intervention

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria IVF/ICSI center. 4 Mogahedin street el Hedaya Alexandria Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria ICSI IVF CENTER 4 Mogahedin street el Hedaya Alexandria Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Alexandria #402 Egypt Hospital

COLLABORATORS
Name Street address City Postal code Country
Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Alexandria Egypt
Tamer Mahmoud Abdel Halim Nafee The Academic Unit of Reproductive and Developmental Medicine, University of Sheffield, Tree Root Walk, S10 2SF. Sheffield United Kingdom
Dalal Elgizery 649 Horryia Avenue Alexandria Egypt
Eman Elgindy Apart 22, building 13, group 76, Rehab City Cairo Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 002 03 5855763
Street address City Postal code Country Position / Affiliation
649 Horryia Avenue Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
Role Name Email Phone Fax
Scientific Enquiries Prof Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 002 03 5855763
Street address City Postal code Country Position / Affiliation
649 Horryia Avenue Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
Role Name Email Phone Fax
Public Enquiries Mr Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 002034251415
Street address City Postal code Country Position / Affiliation
30 Garden City Smouha Alexandria 21516 Egypt Patient Information Manager