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

Freundl 1998.

Study characteristics
Methods Trial design: randomised, double‐blind, comparative study
Participants Participants: 27 women were randomised and analysed.
Mean age: group A: 35 ± 5 years, group P: 34.8 ± 5 years
Inclusion criteria:
  • Age between 18‐45

  • Endometriosis score greater than 5 points causing symptoms and/or sterility

  •  Normal bone density prior to medication

  • Use of contraceptive devices in the 1st month of treatment


Exclusion criteria: not stated 
Setting: Germany
Timing: not stated
Interventions Group A: received a combination of leuprorelin acetate depot with 20 mg ethinyloestradiol plus 0.15 mg desogestrel (n = 14)
versus
Group P: received leuprorelin acetate depot plus placebo (n = 13)
Outcomes
  • Relief of overall pain: endometriosis symptoms

  • Bone mineral density

  • Hypooestrogenic symptoms

  • rAFS score

  • Blood/urine chemistry

  • Body weight

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Contact with the author could not be established for further information; he unfortunately passed away.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Prospective double‐blind, randomised placebo‐controlled trial". 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 Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Incomplete outcome data (attrition bias)
All outcomes Low risk No losses to follow‐up
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