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
Protocol serial number N0256159399
Sponsor Department of Health
Funder The Royal Free Hampstead NHS Trust (UK) NHS R&D Support Funding
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant 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 measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration80
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

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

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