parallel randomized trial

S003422

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Polycystic ovary syndromeS003422

Design

Randomized: 64
Start year: 2023
Treatment: 12 weeks, follow-up 20 weeks
Countries: China (1 sites)
Sponsor: (non industry)
Eligibility: women with infertility and PCOS by Rotterdam criteria; BMI 24 or higher; no diabetes

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment Standard treatment (metformin monotherapy)	metformin 500 mg TID plus lifestyle modification; lifestyle: standard	32	30
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide intensified treatment (semaglutide plus metformin)	metformin 500 mg TID plus lifestyle modification; lifestyle: standard	32	31

Baseline characteristics

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

Characteristic	Statistic	Standard care or no added treatment A1	Semaglutide 1.0 mg subcutaneous once weekly A2
age	mean (years)	31.93	32.77
age	sd (years)	4.81	6.10
bmi	mean (kg/m2)	31.40	31.44
bmi	sd (kg/m2)	3.97	4.30
other regular menstrual cycle	n	13	12
other regular menstrual cycle	percent	43.33	38.71
waist	mean (cm)	96.82	97.40
waist	sd (cm)	7.64	9.45
weight	mean (kg)	82.89	83.86
weight	sd (kg)	9.92	11.55

Analyses this trial contributes to

Results

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

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0046339:p8
	A2	events				0 /	not stated; other; R0046339:p8

Regular menstrual cycles (4 lines; O90B)

Week	Arm	Statistic	Events / N	Detail
12	A1	responders	17 / 30	not stated; completers; R0046339:Table 3
12	A2	responders	24 / 31	not stated; completers; R0046339:Table 3
20	A1	responders	18 / 30	not stated; completers; R0046339:Table 3
20	A2	responders	26 / 31	not stated; completers; R0046339:Table 3