Contact information
Type
Scientific
Primary contact
Dr David Sokal
ORCID ID
Contact details
Family Health International
PO Box 13950
Research Triangle Park
North Carolina
27709
United States of America
+1 919 405 1466
dsokal@fhi.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Study # 9638
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Vasectomy
Intervention
No-scalpel vasectomy by ligation and excision, with fascial interposition versus without fascial interposition
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1999
Overall trial end date
01/06/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Men seeking a vasectomy
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
841
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/1999
Recruitment end date
01/06/2002
Locations
Countries of recruitment
Brazil, El Salvador, Mexico, Nepal, Panama, Sri Lanka, United States of America
Trial participating centre
Family Health International
North Carolina
27709
United States of America
Sponsor information
Organisation
Family Health International (USA)
Sponsor details
PO Box 13950
Research Triangle Park
North Carolina
27709
United States of America
+1 919 544 6979
dgrimes@fhi.org
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Family Health International (USA) - partial support
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
U.S. Agency for International Development (USAID) Cooperative Agreement( (ref: CCP-A-00-95-00022-02) - funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
EngenderHealth (USA) with funds from USAID Cooperative Agreement (ref: HRN-A-00-98-00042-00) - funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15056388
Publication citations
-
Results
Sokal D, Irsula B, Hays M, Chen-Mok M, Barone MA, , Vasectomy by ligation and excision, with or without fascial interposition: a randomized controlled trial [ISRCTN77781689]., BMC Med, 2004, 2, 6, doi: 10.1186/1741-7015-2-6.