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.: PACTR201801002743482 Date of Approval: 02/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative long-term effects of depot medroxyprogesterone acetate, a levonorgestrel implant and a copper intrauterine device on depression and sexual
Official scientific title Comparative long-term effects of depot medroxyprogesterone acetate, a levonorgestrel implant and a copper intrauterine device on depression and sexual dysfunction: An ancillary study of the ECHO* randomised trial
Brief summary describing the background and objectives of the trial Contraceptive method discontinuation is a common cause of unintended pregnancy. Both depression and sexual dysfunction are possible side effects of contraceptive use; however, there is little evidence concerning these effects. Previous research from our unit includes a double blind, placebo controlled trial showing increased postpartum depression in women receiving norethisterone enanthate (NET-EN) versus placebo;1 an unblinded, randomized trial showing reduced libido and greater condom use among women allocated to injectable progestogens versus the copper intrauterine device (IUD);2 and a single blind, randomized trial showing a trend to greater postpartum depression and sexual dysfunction with depot medroxyprogesterone acetate (DMPA) compared with the IUD.3,4 The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial presents an opportunity to determine the comparative effects of three widely used contraceptive methods on depression and sexual dysfunction in the context of a stringent randomized trial protocol.5
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Depression ,sexual dysfunction,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 20/11/2017
Actual trial start date
Anticipated date of last follow up 31/10/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 291
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Random allocation has used a 1:1:1 allocation to the 3 arms of the trial, stratified by site. Random block sizes between 15 and 30 has been used. Allocation to arm has been assigned at the time of randomisation using standardised procedures and a predetermined sequence that is concealed from all study staff prior to randomisation (e.g. opaque, numbered envelopes or on-line or telephonic randomisation system). Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group DMPA (Depot-Provera®, Pfizer) 150mg/mL 12 weeks Injectable hormonal contraceptive 97
Experimental Group LNG implant 150mg (Jadelle®, Bayer Schering Pharma 150mg given once subcutaneously 18 months Implant 97
Experimental Group IUD (Paragard-T 380A®, Duramed). Stat dose 10 years or for 18 Months (Study duration Copper Intra-uterine contraceptive device. 97
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ 16 to 35 years of age ¿ HIV sero-negative at baseline ¿ Seeking effective contraception ¿ Able and willing to provide written informed consent ¿ Agrees to be randomised to either the copper IUD, DMPA, or LNG implant ¿ Agrees to use assigned method for 18 months ¿ Agrees to follow all study requirements ¿ Intends to stay in the study area for the next 18 months and willing and able to provide adequate locator information ¿ If has had a recent third trimester birth, is at least 6 weeks¿ postpartum ¿ Is sexually active (has had vaginal sex within the last 3 months) or has been pregnant within the last 3 months ¿ Agrees not to participate in studies of drugs or vaccines or any other clinical research study while participating in this study Women are not eligible to participate if they have medical contraindications to the IUD, DMPA, or LNG implant (WHO Medical Eligibility Criteria category 3 or 4), 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 29/08/2017 University of Witwatersrand ,HREC(medical)
Ethics Committee Address
Street address City Postal code Country
No.8 Blackwood Avenue, Parktown, Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression When attending 12 month or subsequent ECHO study vist
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Effective Care Research Unit/Cecilia Makiwane Hospital Billie Road Mdantsane 5600 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council. Francie van Zijl Drive, Parow Valley Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Effective Care Research Unit Room 1 admin bloc,Frere Maternity East London 5247 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Theresa A. Lawrie The Old Barn Pipehouse, Freshford Bath Bath BA2 7UJ United Kingdom
Dr Espérance Kashala-Abotnes Centre for International Health Bergen Norway
Prof Michael Berk IMPACT Strategic Research Centre Victoria 3220 Australia
Prof Justus Hofmeyr Room 1 admin bloc,Frere Maternity East London 5247 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mandisa Singata-Madliki mandisa.singata@gmail.com +27824201743 12 Brunsfelsia Road,Nahoon Valley
City Postal code Country Position/Affiliation
East London 5241 South Africa Co-Director /ECRU University of Fort Hare
Role Name Email Phone Street address
Public Enquiries Mandisa Singata-Madliki mandisa.singata@gmail.com +27824201743 Frere Maternity Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5247 South Africa Co-Director, ECRU
Role Name Email Phone Street address
Scientific Enquiries Mandisa Singata-Madliki mandisa.singata@gmail.com +27824201743 Frere Maternity Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5241 South Africa Co-Director /ECRU University of Fort Hare
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information