parallel randomized trial

NCT03151005

Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients

Polycystic ovary syndrome NCT03151005S001582

Design

Randomized: 70
Start year: 2017
Treatment: 12 weeks, follow-up 12 weeks
Countries: China (1 sites)
Sponsor: Xinqiao Hospital of Chongqing (non industry)
Eligibility: Rotterdam PCOS, BMI 24 kg/m2 or more, age 18 to 50 years

Conduct and analysis

Blinding: open label
Sequence generation: other adequate
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Cyproterone ethinylestradiol CPA/EE plus metformin	metformin 500 mg three times daily; lifestyle: none	35	30	30
A2	Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability GLP-1RA (liraglutide) plus metformin	metformin 500 mg three times daily; lifestyle: none	35	30	30

Baseline characteristics

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

Characteristic	Statistic	Cyproterone ethinylestradiol A1	Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability A2
age: 18 or less	n	7	3
age: 18 to 65	n	23	27
age: 65 or more	n	0	0
age	mean (years)	22.43	25.73
age	sd (years)	5.30	4.95
bmi	mean (kg/m2)	27.75	29.23
bmi	sd (kg/m2)	4.47	3.34
female	n	30	30
hba1c	mean (percent)	5.57	5.85
hba1c	sd (percent)	0.37	0.55
other glucose intolerance or diabetes	percent	20	36.67
other regular menstruation	n	7	8
other regular menstruation	percent	23.33	26.67
sbp	mean (mmHg)	121.43	119.30
sbp	sd (mmHg)	13.82	14.41
waist	mean (cm)	93.07	95.78
waist	sd (cm)	9.66	9.59
weight	mean (kg)	71.14	74.56
weight	sd (kg)	10.99	10.20

Analyses this trial contributes to

Results

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

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 30	not stated; completers; registry:adverse_events
	A2	events				0 / 30	not stated; completers; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 30	not stated; completers; R0007146:Supplement Table 1
	A2	events				4 / 30	not stated; completers; R0007146:Supplement Table 1

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 30	not stated; completers; R0007146:Supplement Table 1
	A2	events				4 / 30	not stated; completers; R0007146:Supplement Table 1

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 30	not stated; completers; R0007146:Supplement Table 1
	A2	events				4 / 30	not stated; completers; R0007146:Supplement Table 1

Ovulation (2 lines; O90A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders				1 / 30	not stated; completers; R0007146:Table 1
12	A2	responders				6 / 30	not stated; completers; R0007146:Table 1

Regular menstrual cycles (2 lines; O90B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders	76.66			23 / 30	not stated; completers; R0007146:Table 1
12	A2	responders	73.33			22 / 30	not stated; completers; R0007146:Table 1