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. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

Rotondi 2002.

Study characteristics
Methods Trial design: Randomised trial
Participants Participants: 81 women were randomised in a 2:1 ratio to leuprolide n = 54, or danazol n = 27.
Mean age: mean age not provided; median age was 32 years (range 19‐41)
Inclusion criteria: 
  • Laparoscopically confirmed endometriosis


Exclusion criteria: not stated
Setting: Italy, fertility centre of the second University of Naples
Timing: 1992 to 1999
Interventions Leuprolide acetate 3.75 mg subcutaneously every 28 days, for 6 months
versus
Danazol 200 mg orally three times a day for 6 months
Outcomes
  • Relief of overall pain: subjective symptom scores using a numerical scale

  • Adverse effects

  • rAFS scores

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Note previous version: Excluded from previous version of this review as pain was not an outcome. Included in this review, but did not contribute any data
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomly allocated". 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 No details provided of blinding of participants or personnel
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No details provided of blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk 3/54 women from leuprolide group and 5/27 from danazol group withdrew due to "adverse findings".
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