ACTRN12605000558628RecruitingPhase 4
A randomised, double-blind trial evaluating preoperative medical treatment of endometriosis prior to radical laparoscopic excision of disease to observe the effect on their post-operative outcome with regard to symptomatology, change in quality of life and the ease of completing the procedure and time taken for the procedure.
Department of EndoGynaecology Royal Hospital for Women0 sites150 target enrollmentStarted: September 29, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- ot stated to 35 Years (—)
- Sex
- Female
Inclusion Criteria
- •1.Women who are known to have or suspected to have endometriosis as a cause of their symptoms2. Women who are equally willing to comply with medication administration 3. Women who are able complete questionnaires relating to pain and quality of life4. Women who have histological confirmation of endometriosis at surgery5. Women with suspected endometriosis based on history, clinical examination and current or previous investigations including laparoscopic features of endometriosis would be eligible for entry to the study.
Exclusion Criteria
- •1. Women with a suspected diagnosis of gynaecological malignancy or its precursors2. Women with current or chronic pelvic inflammatory disease3. Women who are currently pregnant or not willing to use barrier contraception during the pre-operative period 4. Women who have a contra-indication to the use of oestrogens such as previous thrombo-embolic disease 5. Women who currently smoke and are over the age of 35 6. Women who have had a previous reaction, or contra-indication to the use of a GnRH analogue7. Women unable to give informed consent8. Women unable or unwilling to attend for a twelve month follow up visit.Note: Previous treatment for endometriosis is NOT an exclusion to trial participation.
Investigators
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