parallel randomized trial

SAXAPCOS

A Randomized Placebo-controlled Double Blind Trial of Liraglutide 3 mg [Saxenda] on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)

Polycystic ovary syndrome NCT03480022S000534

Design

Randomized: 82
Start year: 2018
Treatment: 32 weeks, follow-up 36 weeks
Countries: United States (1 sites)
Sponsor: Woman's Hospital (industry)
Eligibility: premenopausal women 18 to 45 years; PCOS by modified NIH 1990; BMI 30 or more; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3 mg	lifestyle: standard	55	44
A2	Placebo Placebo	lifestyle: standard	27	23

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Liraglutide 3.0 mg subcutaneous once daily A1	Placebo A2
age	mean (years)	31.1	31.8
age	sd (years)	6	5.6
asian	n	0	0
black	n	13	9
bmi	mean (kg/m2)	42	43.9
bmi	sd (kg/m2)	6.7	7.5
female	n	55	27
waist	mean (cm)	111	116
weight	mean (kg)	111	119
white	n	42	18

Analyses this trial contributes to

Results

14 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Percent body weight change (short trials) (2 lines; O10B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
32	A1	percent change	-5.7 percent	0.75		44	not stated; completers; R0022023:Abstract
32	A2	percent change	-1.4 percent	1.09		23	not stated; completers; R0022023:Abstract

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 55	not stated; safety; R0022023:Results
	A2	events				0 / 27	not stated; safety; R0022023:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 55	not stated; randomized; registry:flow
	A2	events				0 / 27	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 55	not stated; safety; R0022023:Table 4
	A2	events				3 / 27	not stated; safety; R0022023:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 55	not stated; safety; R0022023:Table 4
	A2	events				0 / 27	not stated; safety; R0022023:Table 4

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 55	not stated; safety; R0022023:Table 4
	A2	events				0 / 27	not stated; safety; R0022023:Table 4

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 55	not stated; safety; R0022023:Table 4
	A2	events				1 / 27	not stated; safety; R0022023:Table 4