Estrogen, Diabetes, and Endothelial Function

What Was Tested

This registered not phased trial tested Cetrorelix.

This study planned to learn more about women and how the drop in estradiol levels during menopause may affect their cardiovascular risk.

In this study, the investigators examined whether a short-term drop in estrogen levels caused arteries to become stiffer, and explored potential reasons for stiffening arteries.

It had two arms (groups): GnRHant + E2 (active comparator) and GnRHant + PL (placebo comparator).

Participants in this arm received GnRHant and a placebo patch for a period of 1 week.

The registry classes the interventions as drug.

More on the Plan

Participants completed two study visits.

The baseline study visit occurred during the early follicular phase of the menstrual cycle, confirmed via take-home ovulation testing.

Both study visits included collection of anthropometric measures, a fasting blood sample, measures of arterial stiffness, flow-mediated dilation, and endothelial cells via an intravenous catheter.

Who Took Part

40 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Not currently planning to become pregnant. Not currently breastfeeding. No recent history of amenorrhea in the previous 6 months. Consent to data and specimen banking. No use of hormonal contraceptives.

The full record lists 13 inclusion and 2 exclusion criteria; among the exclusions: pregnant and/or breastfeeding; have not had a menstrual cycle in the last 6 months.

How the Study Was Run

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

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

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

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

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

It started in 2010-11-24 with completion listed for 2018-10-22.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Flow-mediated dilation (FMD) at baseline (time frame: 1 week). Flow-mediated dilation (FMD) at follow-up (time frame: 1 week). Change in flow-mediated dilation (FMD) (time frame: Baseline and 1 week).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 40 people.

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

More context: the Cetrorelix compound page, all human trials.