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:
Exclusion criteria: Reduced bone mineral density prior to study entry
Setting: Germany Timing: not stated |
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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 |
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Outcomes |
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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 |
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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 |