Phase 4 · Liraglutide

NCT03151005 trial results

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

Assessment of Reproductive Functions (mIU/ml), 12 weeks. Metformin-GLP-1 Receptor Agonist: 5.52; Metformin-Oral Contraceptive(OC): 5.33.

Participants: 70
Status: completed
Completed: 2021-04-23
Sponsor: Xinqiao Hospital of Chongqing

As posted on ClinicalTrials.gov (NCT03151005), updated at source Dec 4, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT03151005 measured first

Assessment of Reproductive FunctionsmIU/ml · 12 weeks · mean

Metformin-GLP-1 Receptor Agonistn=30	Metformin-Oral Contraceptive(OC)n=30
5.52(3.37)	5.33(2.52)

Side effects by arm

Side effects in NCT03151005

Percent of participants affected, 12 weeks. The most common events the registry lists.

Event	Metformin-GLP-1 Receptor Agonist	Metformin-Oral Contraceptive(OC)
Any serious event	0%	0%
Aminopherase elevation	0%	3.3%

Secondary outcomes

What else it measured

Basic Vital Signskg/m^2 · 12 weeks · mean

Metformin-GLP-1 Receptor Agonistn=30	Metformin-Oral Contraceptive(OC)n=30
26.26(3.67)	27.12(4.04)

Assessment of Liver FunctionIU/L · 12 weeks · mean

Metformin-GLP-1 Receptor Agonistn=30	Metformin-Oral Contraceptive(OC)n=30
39.09(24.16)	36.73(43.12)

Assessment of Blood PressuremmHg · 12 weeks · mean

Metformin-GLP-1 Receptor Agonistn=30	Metformin-Oral Contraceptive(OC)n=30
122.83(10.91)	122.40(6.39)

Assessment of Reproductive Functionnmol/L · 12 weeks · mean

Metformin-GLP-1 Receptor Agonistn=30	Metformin-Oral Contraceptive(OC)n=30
1.82(0.51)	2.14(1.02)

The trial

How NCT03151005 was run

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

Metformin-GLP-1 Receptor Agonist: Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.
Metformin-Oral Contraceptive(OC): Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

Who could join the trial

Inclusion Criteria: * Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism. * Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks. * Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese \[body mass index (BMI) \>=24 kg/m2 or waistline\>=85cm \]. * All subjects had normal thyroid-stimulating hormone and prolactin levels. Exclusion Criteria: * smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions. * age below 18 yr or over 50 yr. * postmenopausal. * uncontrolled hypertension (blood pressure \>=160/100 mm Hg). * preexisting OPs or GLP-1 agonists supplementation * alcohol intake greater than 20 g/d, or pregnancy. * signs of liver or renal failure or active liver disease (ALT \> 2.5× the upper limit of normal values). * PLT\<60\*10\^9/L,Hb\<100g/L, smoking, alcohol use. * The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.

Published papers

Papers from NCT03151005

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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