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An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
Plain-language guide to NCT01403038: phase 1 randomized trial of Elagolix (non-peptide), 216 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01403038
- Phase
- phase 1
- Status
- completed
- Start
- 2011-06
- Completion (planned or actual)
- 2012-10
- Participants
- 216 (actual)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Folliculogenesis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Elagolix (non-peptide).
It had seven arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
More on the Plan
During the Screening and Treatment menstrual cycles, serial transvaginal ultrasounds and determination of serum levels of luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone, and inhibin B will be performed three times weekly.
Subjects will maintain a daily diary of uterine bleeding.
Pregnancy testing will be performed frequently throughout the study.
Who Took Part
Enrollment: 216 actual participants took part.
It was open to women only aged from 18 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Elagolix (non-peptide) group and the comparison group should start out alike.
The Elagolix (non-peptide) group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Elagolix (non-peptide) study: the participants and staff both knew the treatment.
It started in 2011-06 with completion listed for 2012-10.
It ran at 22 sites in United States (20) and Puerto Rico (2).
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Ovulation Classification (time frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3). Ovarian Activity (time frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3).
It also tracked 6 secondary outcomes, for example Endocrine Parameters, Ovarian Reserve, Adverse events, Clinical Laboratory Tests, 12-lead Electrocardiogram and Vital Signs.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Elagolix (non-peptide) in 216 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Elagolix (non-peptide) compound page, all human trials.
Our Notes on the Compound
Elagolix (non-peptide): An oral non-peptide GnRH antagonist (Orilissa) approved for endometriosis pain; combined with add-back hormones (Oriahnn) for fibroid bleeding.
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.