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
Scientific
University Department Of Obstetrics and Gynaecology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Can 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) studied | Urological and Genital Diseases: Pelvic pain |
| Intervention | Randomised Clinical Trial |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/01/2002 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 80 |
| Key inclusion criteria | 40 patients and 40 controls |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Department Of Obstetrics and Gynaecology
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/10/2017: No publications found in PubMed, verifying study status with principal investigator.
