Kökçü 2000.
Methods | Randomised controlled trial | |
Participants | 50 women in spontaneous menopause ≥ 1 year (mean 25 months), still sexually active with a partner with no sexual problems, did not have any gynaecological surgery and had no absolute contraindication for HRT. Mean age 52 years | |
Interventions |
Administered for 1 year |
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Outcomes | Vaginal dryness/dyspareunia, vasomotor symptoms, irregular spotting/bleeding | |
Notes | Timing: unclear Location: Turkey Multi‐centre: no; single site |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specified |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Study authors did not specify whether study drugs were identical looking. They stated that (1) the trial was single‐blind; and (2) the women did not have any previous knowledge and did not receive any information on the possible effects on sexual function of the study drugs. It is then unclear whether they were intended as "blind" just because they were not provided any information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified (and not clear whether the women were blind) |
Incomplete outcome data (attrition bias) All outcomes | High risk | 6/50 women were not evaluated for not attending visits |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
Conflict of interest | Unclear risk | No information about funding or study authors' conflicts of interest |