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.: PACTR201707002431613 Date of Approval: 16/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment of Polycystic Ovary Syndrome in young single women
Official scientific title Evaluation of prolonged use of Statins on the clinical and biochemical abnormalities and ovulation dysfunction in single young women with polycystic ovary syndrome
Brief summary describing the background and objectives of the trial Polycystic Ovary Syndrome (PCOS) affects more than 35% of black women during their reproductive life. PCOS does not only affect the african women reproductive health, but also has a lot of adverse major health problems like diabetes, hypertension, altered lipid profile, heart diseases, and may reach to neoplastic lesions affecting both the uterus, ovary and breast as well. The standard treatment of PCOS through induction of ovulation is not applicable in young single women; so the need for another new treatment management was has become mandatory. The aim of the current work was to investigate the effects of prolonged use of Statins on the clinical and biochemical abnormalities and ovulation dysfunction in young single women with polycystic ovary syndrome (PCOS).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Polycystic Ovary Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2013
Actual trial start date 15/01/2013
Anticipated date of last follow up 15/12/2016
Actual Last follow-up date 31/12/2016
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 Randomisation was through computer software data base Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Simvistatin 20 mg daily 6 months medical treatment 200 Placebo
Control Group Placebo 20 mg 6 months medical treatment 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosed PCOS young single women Aged 16-35 years old -Women recruited had no concurrent illness -21-hydroxylase deficiency, hyperprolactinaemia, Cushing¿s disease and androgen-secreting tumors were excluded by appropriate tests -Women were not on any prescription or over-the-counter medication which might affect insulin sensitivity, lipids or ovarian function 16 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 25/10/2012 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 Improvement of the clinical, and biochemical abnormalities assocaited with PCOS After 3 months After 6 months
Secondary Outcome Spontaneous ovulation improvement After 3 months After 6 months
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 Minia University Obstetrics and Gynecology department Minia University Minia 1357 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emaduldin Seyam Minia University Obstetrics and Gynecology department Minia 1357 Egypt
Saad Al Gelany Minia University Obstetrics and Gynecology department Minia 1357 Egypt
Ahmed Abd Al Ghaney Minia University Obstetrics and Gynecology department Minia 1357 Egypt
Marwa Mohamed Minia University Obstetrics and Gynecology department Minia 1357 Egypt
Enas Hefzy Fayoum University Fayoum 2468 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 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 Saad Al Gelany saad.elgelany@yahoo.co.uk +201003480999 Minai University
City Postal code Country Position/Affiliation
Minia 1357 Egypt Consulatnt Obstetrician and Gynecologist
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