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NCT04003142 · ClinicalTrials.gov registry record · Phase 3
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 501
- Enrollment target
NCT04003142 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 501 participants.
The verdict
NCT04003142, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 501 participants
- Enrollment target
Study Summary
This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments are fezolinetant 30 mg (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study compared fezolinetant and placebo after 4 and 12 weeks of dosing. The study evaluated if fezolinetant reduces the number of hot flashes and the study evaluated if fezolinetant reduces the severity of the hot flashes. Women in the study received an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants used this to record their hot flashes. Their record for the 10 days before the start of study treatment was checked. They remained in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they were picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin. The study participants took study treatment for 52 weeks. The first 12 weeks of study treatment was "double-blinded." That means that the study participants and the study doctors did not know who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg or placebo) during that time. The last 40 weeks of study treatment was "noncontrolled." That means that each study participant and the study doctors knew which study treatment that study participant took during that time. Women who took fezolinetant during the first 12 weeks continued to take the same dose. Women who took placebo during the first 12 weeks took fezolinetant. Their dose was either 30 mg or 45 mg fezolinetant. At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study
Interventions
- DRUG placebo
- DRUG Fezolinetant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2019-07-10 |
| Est. Completion | 2021-04-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04003142
The ClinicalTrials.gov registry entry for NCT04003142 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT04003142 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04003142 about?
NCT04003142 is a clinical study titled "A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2". This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments are fezolinetant 30 mg (1 tablet of fezolinetant and 1 placebo tablet) once a day,...
What is the current status of trial NCT04003142?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 501 participants. The study started on 2019-07-10. Estimated completion is 2021-04-23.
What interventions are being tested in trial NCT04003142?
The interventions under investigation include: placebo (DRUG), Fezolinetant (DRUG).
Who is sponsoring clinical trial NCT04003142?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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