Schlaff 2006.
Study characteristics | ||
Methods | Trial design: multi‐centre, randomised, evaluator‐blinded, comparator‐controlled trial | |
Participants | Participants: 274 women were randomised; 190 women were analysed. Mean age: medroxyprogesterone acetate group 29.2 ± 6.3 years, leuprolide group 32.1 ± 6.6 years Inclusion criteria:
Exclusion criteria:
Setting: United States of America (43 sites) and Canada (7 sites) Timing: not stated |
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Interventions | Subcutaneous depot medroxyprogesterone acetate (DMPA) (104 mg/0.65 mL) every 3 months (n = 136) versus Leuprolide (11.25 mg) intramuscular every 3 months (n = 138) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: yes Sample size calculation: yes Funding: not stated Author contacted; awaiting response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised". No further details of method used to generate the randomisation sequence were provided. |
Allocation concealment (selection bias) | Unclear risk | "An independent person maintained the randomization code, received the study syringes, and administered the study medication". |
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 | Low risk | In this evaluator‐blinded study, the principal investigator and any designated sub‐investigators and study co‐ordinators at each centre were blinded to the randomisation of each participant. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There was a dropout rate of 35.3% in the DMPA‐SC 104 group (48/136) and of 26.1% in the leuprolide group (36/138) during the 6‐month treatment period. The majority of these participants either actively withdrew from the study (DMPA‐SC 104 = 21, leuprolide = 9) or were lost to follow‐up (14 and 11, respectively). Nine patients in each group (6.6% and 6.5% in the DMPA‐SC 104 and leuprolide groups, respectively) discontinued as a result of adverse side effects. Of those women who completed the 6 months of active treatment, 51 (58.0%) of 88 in the DMPA‐SC 104 group and 58 (56.9%) of 102 in the leuprolide group left the study during the 12‐month follow‐up period. |
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 |