Kiilholma 1995.
Study characteristics | ||
Methods | Trial design: Prospective, randomised, double‐blind, placebo‐controlled, comparative study | |
Participants | Participants: 88 women were randomised; 76 women were analysed. Mean age: Goserelin acetate plus HRT treatment mean 32 years (20‐48 years), goserelin acetate plus placebo treatment mean 34 years (21‐47 years) Inclusion criteria:
Exclusion criteria: not stated Setting: Finland Timing: not stated |
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Interventions | 3.6 mg SC goserelin acetate plus HRT treatment with combination of 2 mg 17β‐E2 and 1 mg norethisterone acetate (NET; Kliogest; Novo Nordisk AS, Bagsvaerd, Denmark) (n = 43) versus 3.6 mg SC goserelin acetate plus placebo (n = 45) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: Supported by Zeneca Pharma, Helsinki, Finland. Author could not be contacted due to lack of information. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Prospective, randomized, double‐blind, placebo‐controlled, comparative study". 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 | 76/88 completed study. 35/43 goserelin acetate with hormone replacement therapy and 41/45 goserelin acetate plus placebo group. Two patients discontinued the treatment because of side effects that were considered to be related to the treatment. One of them (goserelin acetate plus placebo) experienced severe depression and the other one had continuous bleeding (goserelin acetate plus HRT). Three women had pregnancy confirmed during the post‐treatment follow‐up period. Two patients underwent surgery for endometriosis, one woman started hormonal contraception, two women were treated with hormonal or IVF therapy for infertility, one patient needed hormonal therapy for a disease other than endometriosis, and one patient did not return. |
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 |