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.: PACTR201508001237608 Date of Approval: 12/08/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Abnormal uterine bleeding
Official scientific title Two regimens of medroxyprogesterone acetate for treatment of endometrial hyperplasia without atypia : a randomized clinical trial
Brief summary describing the background and objectives of the trial to assess the efficacy and acceptability of two regimens of Medroxyprogesterone acetate (MPA) for treatment of endometrial hyperplasia (EH) without atypia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,treatment of endometrial hyperplasia without atypia
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2015
Actual trial start date 22/08/2015
Anticipated date of last follow up 01/03/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1(Cyclic MPA group) 15 mg of medroxyprogesterone acetate for 14 days out of 28 days orally for 6 months. Cyclic MPA group 50
Experimental Group continuous MPA group 15 mg of medroxyprogesterone acetate per day for 21 days out of 28 days orally for 6 months oral intake 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
no prior diagnosis of endometrial carcinoma, an intact uterus, with histologically confirmed endometrial hyperplasia (EH) without atypia Women with associated pathology as uterine fibroid, cervical or vaginal pathology, bleeding tendency, chronic liver disease and any contraindications to progestin therapy were excluded from the study. 40 Year(s) 70 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 19/07/2015 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome regression of hyperplasia after 6 months of progestin therapy. 6 months
Secondary Outcome adverse effects 6 months
Secondary Outcome patient acceptability 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk Kafrmanawahla El-Bajour 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Public Enquiries Ragab Dawood dr_ragabdawood@yahoo.com 002010146256413 10 Quesna
City Postal code Country Position/Affiliation
Quesna 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information