Exenatide and Metformin Therapy in Overweight Women With PCOS

What Was Tested

The trial (phase 2) is built around Exenatide for pcos.

The registry classes the interventions as drug.

More on the Plan

Safety: For safety, all subjects who enter the study are evaluable.

Subjects will be monitored for safety by assessment of adverse events, physical exams, vital signs and laboratory values.

Statistical methods/analysis: The measurement of menstrual frequency involves nominal data ( patients with/without regular cycles pre vs post-treatment and will be analyzed using the McNemar test (complex chi square for paired data).

For all other analyses, in which the data are interval, parameters, such as androgens, lipids, insulin sensitivity, etc. will be evaluated using a SS/Treatment x Trials (pre/post) analyses of variance (ANOVA).

Who Took Part

60 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Must have six or fewer menses /year or be amenorrheic. Have either clinical or laboratory evidence of hyperandrogenism (hirsutism or elevated testosterone (T)) and /or PCOS ovary on ultrasound.

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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 2006-06 with completion listed for 2007-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): - Menstrual Cyclicity ( # menses/ 24 weeks) (time frame: every 4 weeks).

It also tracked 4 secondary outcomes, for example BMI, WHR, FAI (T/SHBG), DHEAS, lipids,abdominal girth,, insulin resistance-(HOMA and composite insulin sensitivity index [ SIOGTT),, and pancreatic ß-cell function (corrected insulin response [CIRgp] and and insulinogenic index [IGI] ).

What This Means in Plain Language

Put simply, this is a phase 2, 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.