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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: www.pactr.org

Trial no.: PACTR201210000420221 Date registered: 2012/09/26
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
Purpose of the trial Prevention
Anticipated trial start date 2012-10-15
Actual trial start date
Anticipated date of last follow up 2013-04-30
Actual date of last follow up
Anticipated target sample size (number of participants) 200   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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
Single group: all participants receive same intervention throughout study Randomised simple randomisation using a randomisation table created by a computer program Sealed opaque envelopes Masking/blinding used

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
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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 35 Years 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 2012/09/28 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 Company

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 Fax
Principal Investigator Mrs Mandisa Singata mandisa.singata@gmail.com +27 43 708 2134 086 65 4322
Street address City Postal code Country Position / Affiliation
Room 68 Admin Block, Cecilia Makiwane Hospital,Mdantsane East London 5201 South Africa Deputy Director
Role Name Email Phone Fax
Public Enquiries Mrs Mandisa Singata mandisa.singata@gmail.com +27 43 708 2134 086 65 4322
Street address City Postal code Country Position / Affiliation
Room 68 Admin Block, Cecilia Makiwane Hospital,Mdantsane East London 5201 South Africa Deputy Director
Role Name Email Phone Fax
Scientific Enquiries Mrs Mandisa Singata mandisa.singata@gmail.com +27 43 708 2134 086 65 4322
Street address City Postal code Country Position / Affiliation
Room 68 Admin Block, Cecilia Makiwane Hospital,Mdantsane East London 5201 South Africa Deputy Director