Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256159399
Study information
Scientific title
Post-operative levonorgestrel-releasing intra uterine system (IUS) treatment after conservative surgery for symptomatic endometriosis stage I to IV to reduce pelvic pain symptoms
Acronym
Study hypothesis
Can we reduce the recurrence of pelvic pain after conservative surgical treatment by inserting the IUS at the time of surgery?
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
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urological and Genital Diseases: Pelvic pain
Intervention
Randomised Clinical Trial
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Reduction in severity of dysmenorrhoea, pelvic pain and deep dyspareunia as assessed by multidimensional analogue questionnaire between the group treated with levonogestrel-IUS and controls
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
40 patients and 40 controls
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Department Of Obstetrics and Gynaecology
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead NHS Trust (UK) NHS R&D Support 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