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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000558628

Acronym

not applicable

Enrollment

150

Registered

2005-09-29

Start date

2002-01-11

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 35 Years

Healthy volunteers

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.

Outcome results