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.: PACTR201701001900640 Date of Approval: 01/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Contraception
Official scientific title Impact of Levonorgestrel Intrauterine System versus Copper IUD on menstrual changes and uterine artery Doppler indices: a randomized clinical trial
Brief summary describing the background and objectives of the trial to assess the impact of Levonorgestrel Intrauterine System versus Copper IUD on menstrual changes and uterine artery Doppler waveforms.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Contraception,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 12/12/2016
Actual trial start date 14/12/2016
Anticipated date of last follow up 18/06/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I (Levonorgestrel IUS): LNG-IUS 3 years contraception 150
Experimental Group Group II (Copper IUD): Copper IUD 10 years contraception 150
Experimental Group LNG-IUS LNG-IUS inserted 3 years 150
Experimental Group Group I (Levonorgestrel IUS) LNG-IUS inserted 3 years contraception 150
Experimental Group Group II (Copper IUD): copper IUD inserted 10 years contraception 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women requesting long-acting reversible contraception (LARC) who fulfilled the criteria for IUD insertion. Pregnancy, undiagnosed genital bleeding, breastfeeding, previous genital infection in the preceding 3 months, medical disorders and any contraindication to IUD insertion or progestin administration. 20 Year(s) 45 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 20/11/2016 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 menstrual changes and changes in uterine artery Doppler indices after 3 and 6 months of use. menstrual changes and changes in uterine artery Doppler indices after 3 and 6 months of use.
Secondary Outcome : adverse effects of the method and patient acceptability. : adverse effects of the method and patient acceptability.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MCH centers 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia governorate 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 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Public Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 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 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 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
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