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.: PACTR201710002641118 Date of Approval: 24/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Management of Polycystic Ovarian Syndrome in young women
Official scientific title Effects of combined prolonged Simvastatin and Metformin treatment on the clinical abnormalities and ovulation dysfunction in single young women with polycystic ovary syndrome
Brief summary describing the background and objectives of the trial Polycystic ovarian syndrome is a the most common reproductive disorder in women, especially those dark skinned. Early management of this disorder in young aged women would definitely help to solve this great problem after marriage. Using Statins and Metformin had succeeded to solve all the abnormal metabolic and endocrine variables, in addition to the characteristic ovulation dysfunction associated with PCOS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Polycystic Ovary Syndrome PCOS
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/09/2013
Actual trial start date 24/09/2013
Anticipated date of last follow up 30/09/2016
Actual Last follow-up date 30/09/2016
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined Metformin and Simvastatin 500 mg Meformin + 20 mg Simvastatin 6 months medical treatment 70 Active-Treatment of Control Group
Control Group Simvistatin Simvastatin 20mg 6 months medical treatment 65
Control Group Metformin Metformin 20mg 6 months medical treatment 65
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A randomized, double-blind controlled study was performed using combined Simvastatin and metformin with PCOS unmarried women in a tertiary care centre in Upper Egypt. The diagnosis of PCOS was based on the availability of the three diagnostic criteria of the Rotterdam consensus, namely clinical and biochemical evidence of hyperandrogenaemia (Ferriman-Gallwey score (FGS), free androgen index (FAI) respectively), oligomenorrhea or amenorrhea and polycystic ovaries on transabdominal ultrasound Women recruited had no concurrent illness, and were not on any prescription or over-the-counter medication which might affect insulin sensitivity, lipids or ovarian function including hormonal contraceptives for the preceding six months. 21-hydroxylase deficiency, hyperprolactinaemia, Cushing¿s disease and androgen-secreting tumors were excluded by appropriate tests. All women were young unmarried and not planning to marry at least till the end of study period. Recruited women were advised not to change their lifestyle, including physical activity or dietary habits, during the study period 18 Year(s) 35 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 26/09/2015 Minia University Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Minia University Minia 1357 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Spontaneous ovulation improvement Sonographic confirmation of at least 18 mm follicle Mid-luteal progesterone level
Secondary Outcome Improvement of the clinical, and biochemical abnormalities assocaited with PCOS After 3 and 6 months of the combined treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University Obstetrics and Gynecology department Minia University Minia 1357 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minia University Obstetrics and Gynecology department Minia University Minia 1357 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Emaduldin Seyam Minia University Minia 1357 Egypt Funding Agency
Secondary Sponsor Minia University Obstetrics and Gynecology department Minia University Minia 1357 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emaduldin Seyam Minia University Minia 1357 Egypt
Enas Hefzy Minia University Minia 1357 Egypt
Saad Al Gelany Minia University Minia 1357 Egypt
Ahmed Abd Al Ghaney Minia University Minia 1357 Egypt
Marwa Mohamed Minia University Minia 1357 Egypt
Ayman Moheb Minia University Minia 1357 Egypt
Eissa Khalifa Minia University Minia 1357 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emaduldin Seyam eemsseyam@yahoo.com +201003480999 Minai University
City Postal code Country Position/Affiliation
Minia 1357 Egypt Snior Consulatnt Obstetrician and Gynecologist
Role Name Email Phone Street address
Public Enquiries Marwa Mohamed dr_marwa_mymh@yahoo.com +201003480999 Minai University
City Postal code Country Position/Affiliation
Minia 1357 Egypt Specialist in Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Enas Hefzy emhefzy@yahoo.com +201003480999 Minai University
City Postal code Country Position/Affiliation
Minia 1357 Egypt Asistant Professor in Immunology
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information