Cardiometabolic Consequences of the Loss of Ovarian Function

What Was Tested

The trial (phase 4) is built around Degarelix.

It had two arms (groups): Degarelix plus transdermal placebo (experimental) and Degarelix plus transdermal estradiol (experimental).

At baseline \& 10 weeks: 80-mg subcutaneous injection of degarelix acetate plus Placebo transdermal patch (applied twice per week).

The registry classes the interventions as drug.

More on the Plan

The oxidative stress-mediated vascular dysfunction was related to the loss of estrogen.

TRP is an essential amino acid that is metabolized to KYN and various metabolites.

It is unknown if estrogen regulates this pathway.

Women will wear a patch daily that will be switched out weekly.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to women only aged from 20 years up to 45 years.

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

Examples of who could join: Age criteria of 20-45 years: the investigators are determining the effects of ovarian suppression on adiposity and vascular in premenopausal women;. Not pregnant or planning to become pregnant;. Not lactating in the last 3 months;. Not on hormonal contraception in the last 3 months;. Sedentary or recreationally active (\<2 days/wk vigorous exercise);.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: body mass index (bmi) \>35 kg/m2;; weight change \>5 kg in the last 3 months;; use of glucocorticoids (inhaled, oral, topical) or drugs that affect glucocorticoid metabolism (e.g., ketoconazole) in the last 3 months;.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Degarelix.

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

It started in 2024-06-01 with completion listed for 2028-05-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Brachial artery flow mediated dilation (FMD) (time frame: Baseline and at 2 and 20 weeks).

It also tracked 1 secondary outcome, for example Visceral fat area (VFA).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Degarelix in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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