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Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix
Plain-language guide to NCT03240159: phase 3 randomized trial of Degarelix, 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03240159
- Phase
- phase 3
- Status
- status unknown
- Start
- 2017-02-15
- Completion (planned or actual)
- 2021-06-30
- Participants
- 120 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Pregnancy, Ovarian
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Degarelix.
It had three arms (groups): one (active comparator), one (active comparator) and one (active comparator).
The registry classes the interventions as drug.
More on the Plan
On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
Who Took Part
Enrollment: 120 planned participants were the target.
It was open to women only aged from 18 years up to 39 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age 18-39 years; body mass index (BMI) 18-29kg/m2;. Regular menstrual cycle of 26-35days,. Presumed to be ovulatory;.
The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: women with diabetes and other metabolic disease; women with heart disease, qt prolongation,heart failure; elevated liver enzymes, liver failure, hepatitis.
How the Study Was Run
It was run as a randomized, parallel-group and open-label 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.
Being open-label, the Degarelix study did not mask who received what.
It started in 2017-02-15 with completion listed for 2021-06-30.
It ran at 1 site in Greece.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: LH levels (time frame: 4 days after injection of Degarelix).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Degarelix in 120 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Degarelix compound page, all human trials.
Our Notes on the Compound
Degarelix: A GnRH antagonist injection (Firmagon) for advanced prostate cancer that lowers testosterone within days without the initial surge seen with agonists.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.