Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.

What Was Tested

This registered phase 4 trial tested Exenatide for pcos.

To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS patients were collected from Shengjing hospital.

The intervention period was 3 months after intervention with met or met + GLP-1.

It had four arms (groups): Metformin (BMI<24) (active comparator), Metformin (BMI≥24) (experimental), Combination (BMI<24) (experimental) and Combination (BMI≥24) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria. Overweight/obesity (BMI≥24 kg/m2). No pregnant plan in recent 6 months. Written consent for participation in the study.

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: type 1 or type 2 diabetes mellitus; subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, cushing's syndrome, thyroid diseases, and hyperprolactinemia; diagnosed with or have a family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

Nothing was hidden in this open-label Exenatide study: the pcos participants and staff both knew the treatment.

It started in 2021-01-04 with completion listed for 2022-01-04.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in body weight (time frame: 12 weeks).

It also tracked 17 secondary outcomes, for example Change in body mass index (BMI), Change in waist circumference(WC), Change in Ferriman-Gallwey score, Change in Acne severity score, Changes in frequency of menstrual cycle and Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 60 people with pcos.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, PCOS research.