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

NEET 1992.

Study characteristics
Methods Trial design: Multi‐centre, parallel, randomised, double‐blind, double‐dummy study
Participants Participants: 315 women were randomised, 307 were analysed for safety and 263 were analysed for efficacy.
Mean age: not stated 
Inclusion criteria: 
  • Laparoscopically diagnosed endometriosis 18‐45 years old 

  • Not pregnant 

  • Pap smear negative for malignancy 

  • Normal menstrual cycle 21‐36 days for previous 4 months 

  • Weight between 45‐110 kg 


Exclusion criteria: 
  • Amenorrhoea 

  • Concurrent disease which may interfere with endometriosis or contraindicate the use of androgenic therapy 

  • Surgical treatment at baseline or within 6 months prior to study 

  • Use of danazol, androgenic hormones, oestrogens, or progestogens within 3 months prior to study 


Setting: Multiple sites within Europe 
Timing: not stated
Interventions Nafarelin 200 mcg twice daily intranasal + placebo per os for 6 months (n = 206) 
versus 
Danazol 200 mg three times a day per os + placebo intranasal for 6 months (n = 101) 
Outcomes
  • Relief of overall pain: dysmenorrhoea, dyspareunia, pelvic pain, pelvic tenderness and induration 

  • Adverse effects

  • AFS score 

Notes Intention‐to‐treat analysis: no
Sample size calculation:  not stated
Funding: Supported in part by Syntex Research, Palo Alto, California, US
Note previous version: 8 participants who were randomised never took the study medication.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "patients were randomised so that 2 were assigned to receive nafarelin for every 1 assigned to receive danazol". No further information was provided on method used to generate random sequence.
Allocation concealment (selection bias) Unclear risk No details were provided of method used to conceal treatment group allocation.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind study
Incomplete outcome data (attrition bias)
All outcomes Low risk Detail for attrition: 
  • "307 were included in the safety analyses, of whom 263 also qualified for the efficacy analyses (171 nafarelin and 92 danazol recipients)" 

  • 25 had been treated < 150 days 

  • 7 were treated > 150 days but refused or otherwise missed the post‐treatment laparoscopy 

  • 12 violated the study protocol 

  • 14 discontinued due to adverse events 

  • 4 for intercurrent illness 

  • 4 for personal reasons 

  • 1 due to ineffective treatment 

  • 2 lost 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