The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

What Was Tested

The trial (phase 4) is built around Exenatide and Liraglutide for pcos.

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.

It had two arms (groups): Metformin-GLP-1 Receptor Agonist (experimental) and Metformin-Oral Contraceptive(OC) (active comparator).

The registry classes the interventions as drug.

More on the Plan

Groups: Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

Time Point: Initial treatment; Post-treatment (4w); Post-treatment (8w); Post-treatment (12w); Assess reproductive functions and cardiovascular risk factors.

Who Took Part

Enrollment: 70 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: 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.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: 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; uncontrolled hypertension (blood pressure \>=160/100 mm hg).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

The Exenatide group and the comparison group ran side by side rather than switching.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2017-07-01 with completion listed for 2021-04-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Assessment of Reproductive Functions (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example Basic Vital Signs, Assessment of Liver Function, Assessment of Blood Pressure and Assessment of Reproductive Function.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Liraglutide in 70 people with pcos.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page and the Liraglutide compound page, PCOS research.