Post-operative levonorgestrel-releasing intra uterine system (IUS) treatment after conservative surgery for symptomatic endometriosis stage I to IV to reduce pelvic pain symptoms

ISRCTN ISRCTN51782640
DOI https://doi.org/10.1186/ISRCTN51782640
Secondary identifying numbers N0256159399
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
18/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Adam L Magos
Scientific

University Department Of Obstetrics and Gynaecology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePost-operative levonorgestrel-releasing intra uterine system (IUS) treatment after conservative surgery for symptomatic endometriosis stage I to IV to reduce pelvic pain symptoms
Study objectivesCan we reduce the recurrence of pelvic pain after conservative surgical treatment by inserting the IUS at the time of surgery?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Pelvic pain
InterventionRandomised Clinical Trial
Intervention typeOther
Primary outcome measureReduction 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 measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants80
Key inclusion criteria40 patients and 40 controls
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/01/2002
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Department Of Obstetrics and Gynaecology
London
NW3 2QG
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

The Royal Free Hampstead NHS Trust (UK) NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

18/10/2017: No publications found in PubMed, verifying study status with principal investigator.