Napolitano 2015.

Methods	Design: prospective study Location: menopause clinic in Italy Time frame: enrolled January 2011 to January 2014 Sample size estimation and outcome of focus: based on prior experience, 11 subjects needed per group to document between‐group difference in fat mass (FM) of 1.2 kg ± 0.6; no power analysis reported
Participants	110 women Inclusion criteria: perimenopausal based on serum FSH > 15 IU/ml and irregular menstrual cycles or amenorrhea < 3 months (aged 45 to 55 years) Exclusion criteria: current hormone use; sterilization; BMI < 18 or > 30; vascular disease or coagulation disorder; hypersensitivity to study drug ingredient; thyroid dysfunction; fasting glucose > 110 mg/dl; breast or gynecologic disease
Interventions	1) Desogestrel (DSG) 75 µg OC (N = 44) 2) LNG‐IUC (N = 35) 3) Control, no contraception (N = 31)
Outcomes	Change in weight (kg), BMI, fat mass (%), fat free mass (%), waist (cm), waist to hip ratio, resting metabolic rate (kJ/24 h) Follow‐up: 12 months
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Women chose method
NOS selection (NRS)	Low risk	Exposed: menopause clinic population, volunteered for study Non‐exposed: same population as exposed Exposure: clinic records (clinic inserted IUC)
NOS comparability (NRS)	High risk	Analysis: unadjusted
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not feasible due to women having chosen contraceptive method
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No mention; objective outcome measure
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up or discontinuation: 7% (8/110); DSG OC 4.5% (2/44), LNG‐IUC 3% (1/35), and control 16% (5/31); control had 2 lost to follow‐up (6%)