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NCT04003389 · ClinicalTrials.gov registry record · Phase 3
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,831
- Enrollment target
NCT04003389 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 1,831 participants.
The verdict
NCT04003389, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,831 participants
- Enrollment target
Study Summary
This study was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study was to find out how safe it is for these women to take fezolinetant in long term (up to 52 weeks). To do that, the study looked at the number and severity of the "adverse events." Those were the side effects that study participants had while they were in the study. The study treatments were fezolinetant 30 milligrams (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 was a dummy treatment that looked like medicine but did not have any medicine in it.) Women in this study were picked for 1 of the 3 study treatments by chance alone. The study participants took study treatment for 52 weeks. This study 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). At weeks 2 and 4 and then once a month, the study participants went to the hospital or clinic for a check-up. They were asked about medications, side effects and how they felt. Other checks included physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine were collected for laboratory tests. At some study visits, study participants completed questionnaires that were about their quality of life. At the first and last study visits, they had a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA created pictures of the inside of these areas with low-dose x-rays. (The dose was approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still had their uterus had 2 more tests done at the first and last study visits. One of the 2 tests was endometrial biopsy. T
Interventions
- DRUG placebo
- DRUG fezolinetant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,831 participants |
| Start Date | 2019-07-10 |
| Est. Completion | 2022-01-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04003389
The ClinicalTrials.gov registry entry for NCT04003389 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,831 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.
NCT04003389 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04003389 about?
NCT04003389 is a clinical study titled "A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause". This study was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study was to find out how safe it is for these women to take fezolinetant in long term (up to 52 week...
What is the current status of trial NCT04003389?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,831 participants. The study started on 2019-07-10. Estimated completion is 2022-01-04.
What interventions are being tested in trial NCT04003389?
The interventions under investigation include: placebo (DRUG), fezolinetant (DRUG).
Who is sponsoring clinical trial NCT04003389?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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