Skip to main content
. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

Audebert 1997.

Study characteristics
Methods Trial design: Open, multi‐centre, central randomised study
Participants Participants: 120 eligible women; 71 were randomised; 55 were analysed 
Mean age: 31 ± 5.9 years 
Inclusion criteria: 
  • Laparoscopically diagnosed endometriosis 

  • Symptomatic 

  • Recurrence of endometriosis after surgery 

  • Over 18 years old 

  • No other hormone therapy except insulin 


Exclusion criteria: 
  • Amenorrhoea 

  • Patient having had hysterectomy 

  • Pregnant women 

  • Serious illness e.g. liver disease 


Setting: France 
Timing: January 1989 to February 1991
Interventions Leuprorelin 3.75 mg SC depot every 28 days for 24 weeks (n = 33) 
versus 
Danazol 600‐800 mg PO daily for 24 weeks (n = 22)
Outcomes
  • Relief of overall pain: dysmenorrhoea, dyspareunia, pelvic pain, induration and pelvic tenderness 

  • rAFS score 

  • Adverse effects

Notes Intention‐to‐treat analysis: yes
Sample size calculation: not stated
Funding: not stated
Note previous version: Could not use data unless mean and SD specified; author contacted. Author replied that study was sponsored by a pharmaceutical company who hold the raw data. He is attempting to locate a contact for further information.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Central randomisation". No further details of method used to generate the randomisation sequence were provided.
Allocation concealment (selection bias) Unclear risk No details of method used to conceal allocation were provided.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Open‐label study. No details provided of blinding of participants or personnel
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention of blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Low risk Sufficient reporting of attrition: 
  • Refused 2nd laparoscopy n = 1 (leuprolide acetate) 

  • Lost to follow‐up n = 2 (leuprolide acetate) and n = 9 (danazol) 

  • Progression of disease n = 2 (danazol) 

  • Not meeting protocol n = 1 (danazol) 

  • Other n = 1 (danazol)

Selective reporting (reporting bias) Low risk The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified.
Other bias Low risk No other risk of bias detected