Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

What Was Tested

This registered early phase 1 trial tested Cetrorelix for menopause & perimenopause.

Also with aging, the functioning of the arteries declines.

It had three arms (groups): Pre or Early perimenopausal 1 (experimental), Pre or Early Perimenopausal 2 (experimental) and Late Perimenopausal and Postmenopausal (experimental).

Subjects randomized to either 1) KUVAN crossover to placebo OR 2) placebo crossover to KUVAN No hormone modification.

The registry classes the interventions as drug.

More on the Plan

Their research has investigated the mechanisms underlying endothelial protection of E2 including how hormonal fluctuations during the peri-to early postmenopausal years contribute to endothelial dysfunction, and how these hormonal changes might interact with aging.

These data indicate that E2 may protect the vasculature from free radical injury during pre- and early perimenopausal years.

Tetrahydrobiopterin (BH4) is a critical co-factor in the production of NO by endothelial nitric oxide synthase (eNOS), and in the face of deficient levels, uncoupling of eNOS results in the production of ROS instead of NO.

The global aim of this renewal is to follow-up on their previous findings and to determine the role of BH4 as a mediator of endothelial dysfunction \[across the stages of the menopausal transition and aging in women.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to women only aged from 18 years up to 70 years.

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

Examples of who could join: Age criteria established for pre-, peri- and postmenopausal women, and if postmenopausal at least 1 year beyond menopause. Sedentary or recreationally active (\<3 days of vigorous aerobic exercise). No use of OCs, HT, or other medications that might influence cardiovascular function. No use of vitamin supplements, NSAIDS or willing to stop use for duration of the study. Not taking any other medications that would interact with cetrotide, E2 patch, or Kuvan® to confound interpretation of results.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: history of or active estrogen-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia, and cvd; history of stomach ulcer or bleeding; other contraindications to hrt, gnrhant, and kuvan (i.e., taking levodopa, medications that can inhibit folate metabolism including methotrexate).

How the Study Was Run

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

The menopause & perimenopause participants were allocated by chance, so the Cetrorelix group and the comparison group should start out alike.

Groups ran in parallel: each of the menopause & perimenopause participants stayed in one arm throughout.

Neither the menopause & perimenopause participants nor the staff measuring them knew who was on Cetrorelix, so expectations could not easily colour the readings.

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

It started in 2013-12 with completion listed for 2016-05-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change in brachial artery flow-mediated dilation (time frame: 4-5 years).

It also tracked 1 secondary outcome, for example Change in carotid artery compliance and endothelial cell protein expression.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Cetrorelix in 100 people with menopause & perimenopause.

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

More context: the Cetrorelix compound page, Menopause & perimenopause research.