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

Gnoth 1999.

Study characteristics
Methods Trial design: Randomised, double‐blind, placebo‐controlled, prospective trial
Participants Participants: 27 women were randomised and analysed.
Mean age: group 1; 34.8 ± 5 years, group 2; 35 ± 5 years
Inclusion criteria:
  • Laparoscopically confirmed endometriosis (rAFS I‐IV)

  • No hormonal pretreatment at least 8 weeks prior to study entry

  • Age 18‐45

  • Normal bone mineral density prior to study entry


Exclusion criteria: 
Reduced bone mineral density prior to study entry
  • Absolute or relative contraindication against ethinyl oestradiol or desogestrel

  • Pregnancy

  • Medical history or any event of thrombosis

  • Any form of haemoglobin disorders, hypertension, liver function disorders, any history of malignant diseases, any oestrogen‐related disorders like otosclerosis, herpes gestationis, history of severe pruritus in pregnancy 

  • Additional medication with: antiepileptics, antibiotics, rifampicin, isoniazid, phenylbutazon, griseofulvin, chlorpromazin, nitrofurantoin or dihydroergotamin


Setting: Germany
Timing: not stated
Interventions Group 1: leuprolin acetate 3.75 mg IM + oral placebo each day
versus
Group 2: leuprolin acetate 3.75 mg IM + 20μg ethinyl oestrodiol and 0.15 mg desogestrel
per day
Outcomes
  • Bone mineral density

  • Pyridinoline concentrations in urine

  • Calcium: serum and urinary concentrations

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Author contacted for more information regarding selection bias; awaiting response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk By centralised randomisation process. 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‐blinded, placebo‐controlled study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blinded, placebo‐controlled study
Incomplete outcome data (attrition bias)
All outcomes Low risk Pretreatment measurements of one women weres not done.
1 early pregnancy post‐treatment. The reply from the authors stated that there
were no exclusions post‐randomisation or losses to follow‐up, but remarked
that one woman withdrew directly after the first medical investigation and
randomisation. She did not tell the reasons for her decision. There were no measurements taken
from her. This participant was completely excluded from the evaluation and replaced.
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