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.: PACTR201210000420221 Date of Approval: 26/09/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of the copper intrauterine device and injectable progestogen contraceptive on depression and sexual functioning
Official scientific title A randomised control trial studying the effects of the copper intrauterine device and injectable progestogen contraceptive on depression and sexual functioning of women in the Eastern Cape
Brief summary describing the background and objectives of the trial Contraceptive non-use and method discontinuation are common causes of unintended pregnancy. The most common reason for method discontinuation is unacceptable side effects. This study will examine the potential association between two highly effective forms of contraception, the copper intrauterine device (IUD) and injectable progestogen, and mood disorders. The study will specifically investigate the impact that initiation of an IUD or injectable progestogen has on depressive symptoms and sexual functioning. Both depression and sexual dysfunction are given as side effects of contraceptive use; however, limited data exists to substantiate this claim.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied depression,sectual functioning,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/10/2012
Actual trial start date
Anticipated date of last follow up 30/04/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
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
Randomised simple randomisation using a randomisation table created by a computer program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Copper T380A 3 months insertion of a Copper T 380A IUD 100 Active-Treatment of Control Group
Control Group (Injectable progestogen group - DMPA 150 milligrams 3 monthly intervals The ¿depot¿ injection is a hormone injection, which lasts for 3 months 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women of child bearing age between 18 to 35 years Women with no evidence of active pelvic infection Women who have no contraindications to injectable Progestogen or IUD Women who are prepared to use either method of contraception Women delivered less than 48 ago. Women who are willing and able to give consent. Recent noticed vaginal bleeding that is unusual. Any contraindication for deport injection and IUD as stated on the WHO contraceptive eligibility criteria will. Women at baseline screening with depression score of 29 - 63(severe depression) Women with no access to telephone 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
No 28/09/2012 University of Cape TownHuman Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E 52, Room 24, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome depression and sexual functioning 1 month 3 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cecilia Makiwane Hospital Billie Road Mdantsane 5219 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Effective Care Research Unit Frere Martenity,Amalinda Drive East London 5201 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Effective Care Research Unit Frere Martenity,Amalinda Drive East London 5201 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
University of Cape Town Groote Schuur Hospital Observatory Cape Town 7905 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mandisa Singata mandisa.singata@gmail.com +27 43 708 2134 Room 68 Admin Block, Cecilia Makiwane Hospital,Mdantsane
City Postal code Country Position/Affiliation
East London 5201 South Africa Deputy Director
Role Name Email Phone Street address
Public Enquiries Mandisa Singata mandisa.singata@gmail.com +27 43 708 2134 Room 68 Admin Block, Cecilia Makiwane Hospital,Mdantsane
City Postal code Country Position/Affiliation
East London 5201 South Africa Deputy Director
Role Name Email Phone Street address
Scientific Enquiries Mandisa Singata mandisa.singata@gmail.com +27 43 708 2134 Room 68 Admin Block, Cecilia Makiwane Hospital,Mdantsane
City Postal code Country Position/Affiliation
East London 5201 South Africa Deputy Director
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