RecruitingPhase 4ACTRN12605000558628

A randomised, double-blind trial evaluating preoperative medical treatment of endometriosis prior to radical laparoscopic excision of disease

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.


Sponsor

Department of EndoGynaecology Royal Hospital for Women

Enrollment

150 participants

Start Date

Jan 11, 2002

Study Type

Interventional

Conditions

Summary

This study will treat women with either one of two medications or placebo for three months prior to their surgery 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.


Eligibility

Sex: FemalesMax Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether taking medication for three months before surgery to remove endometriosis can improve the results of the operation. Endometriosis is a condition where tissue similar to the lining of the uterus grows outside it, causing pain and other problems. Women in this study will be randomly assigned to one of two medications or a placebo (sugar pill) for three months before their laparoscopic (keyhole) surgery. Researchers will check whether this improves pain, quality of life, and how easy the operation is to complete. You may be eligible if: - You are a woman under 35 years of age - You are known to have, or suspected to have, endometriosis as the cause of your symptoms - You are willing to take the study medication as directed - You are able to complete questionnaires about pain and quality of life - You are willing to use barrier contraception before surgery You may NOT be eligible if: - There is any suspicion of gynaecological cancer - You have current or chronic pelvic inflammatory disease - You are pregnant or unwilling to use barrier contraception - You have a contraindication to oestrogens (e.g., a history of blood clots) - You are over 35 and currently smoke - You have had a reaction to a GnRH analogue medication in the past - You are unable to give informed consent or attend a 12-month follow-up Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

1. Three months of the continuous oral contraceptive pill + placebo GnRH analogue 2. Three months of GnRH analogue + placebo pill

1. Three months of the continuous oral contraceptive pill + placebo GnRH analogue 2. Three months of GnRH analogue + placebo pill


Locations(1)

Australia

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