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.: PACTR201908498370196 Date of Approval: 22/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Metformin versus Levonorgestrel-Releasing Intrauterine Device (MIRENA) in the Management of Endometrial Hyperplasia
Official scientific title Metformin versus Levonorgestrel-Releasing Intrauterine Device (MIRENA) in the Management of Endometrial Hyperplasia
Brief summary describing the background and objectives of the trial Endometrial hyperplasia is a pathologic condition affecting middle aged women. Different treatment modalities are available. The aim of this trial is to compare the efficacy of metformin versus levonorgestrel-releasing intrauterine device (mirena) in the treatment of endometrial hyperplasia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied endometrial hyperplasia
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/08/2019
Actual trial start date 25/08/2019
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date 01/07/2020
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 randomization using a randomization 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
Control Group mirena group levonorgestrel intrauterine device will be inserted for patients with endometrial hyperplasia for 6 months 6 months participants will use levonorgestrel-releasing intrauterine device (mirena) for 6 months. 25 Active-Treatment of Control Group
Experimental Group metformin group metformin 850 mg orally for 6 months in the form of once daily for 2 months and then twice daily for 4 months. 6 months metformin 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Women between the ages of 18-75 years old. 2- Women with a histological diagnosis of endometrial hyperplasia without atypia confirmed by endometrial biopsy. 1- Pregnant women. 2- Women with contraindication to Metformin (Impaired renal functions , Cirrhosis of the liver, Hepatitis and Alcoholism). 3- Women with contraindications to Mirena (e.g. acute genital tract inflammatory disease, genital bleeding of unknown etiology, hypersensitivity to any component of this product, congenital or acquired uterine anomaly, known or suspected breast cancer, known or suspected uterine and cervical neoplasia or acute liver disease or liver tumor). 4- Women with concurrent endometrial cancer . 5- Women with a history of a hormone-dependent malignancy (e.g. breast cancer). 6- Women taking tamoxifen. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 27/05/2019 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies. 6 months after treatment
Secondary Outcome intervention related side effects 6 months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
omima tharwat taha ring road kilo 4.5 ismailia Egypt
Mohammad Mokhtar Shaaban ring road kilo 4.5 ismailia Egypt
Eman Kishk ring road kilo 4.5 ismailia Egypt
Mohammed Mohsen Abdelgelil ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Abdelgelil drmody1104@gmail.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing data will be through the results of the research after approval of the ethics committee Study Protocol 2 months after the end of the trial through the research after approval of our research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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