Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

Plain-language guide to NCT03383068: phase 4 randomized trial of Exenatide, pcos, 160 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03383068
Phase: phase 4
Status: status unknown
Start: 2018-01-01
Completion (planned or actual): 2018-12-31
Participants: 160 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: PCOS; Impaired Glucose Tolerance
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Exenatide for pcos.

By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.

It had four arms (groups): control (other), acarbose (experimental), Exenatide (experimental) and Orlistat (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 160 planned participants were the target.

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: PCOS women at Childbearing Age. PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the 2003 Rotterdam criteria.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: history of current or past pregnancy; hormonal contraceptive or metformin use within 3 months of enrollment; nonclassical congenital adrenal hyperplasia.

How the Study Was Run

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

The pcos participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-01-01 with completion listed for 2018-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 160 people with pcos.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, PCOS research.

Our Notes on the Compound

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.