Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

What Was Tested

The trial (phase 2) is built around Degarelix.

The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 85 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

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

Examples of who could join: Signed Informed Consent Form, prior to screening evaluations. In good physical and mental health. Pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of randomisation. Regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be ovulatory. Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive).

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: abnormal karyotype; any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study; diagnosed with polycystic ovarian syndrome or endometriosis stage iii/iv.

How the Study Was Run

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

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

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

Only one side, usually the participants, was kept unaware of whether Degarelix was given.

Those kept unaware of assignments: investigator.

It started in 2007-03 with completion listed for 2007-12.

It ran at 4 sites in Spain (2), Belgium (1) and Czechia (1).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm) (time frame: Stimulation Day 1).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 85 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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