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: pactr.samrc.ac.za
Trial no.: PACTR201307000567163 Date of Approval: 18/06/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology,Polycystic ovarian syndrome
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/02/2010
Actual trial start date 15/02/2010
Anticipated date of last follow up 30/10/2013
Actual Last follow-up date 30/10/2013
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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 Participants
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 Age Category Minimum age Maximum 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 Year(s) 19 Year(s) 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 10/02/2010 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 Street address
Principal Investigator Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information