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NCT05312567 · ClinicalTrials.gov registry record · Phase 2
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
A Phase 2 study of Menopause and Vasomotor Symptoms, sponsored by Fervent Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 12
- Study locations
NCT05312567 is a Phase 2 study of Menopause and Vasomotor Symptoms that has completed, run by Fervent Pharmaceuticals. The registered enrollment target is 105 participants, below the 9,392-participant average among 54 other Menopause trials with a reported enrollment target (99% lower). The trial reports 12 study locations across 6 states.
The verdict
NCT05312567, a Phase 2 study of Menopause and Vasomotor Symptoms, has completed, sponsored by Fervent Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 12
- Study locations
Study Summary
This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101 (60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period of 1-week.
Conditions Studied
Interventions
- DRUG FP-101
Study Locations (12)
California
- Torrance Clinical Research Institute - Lomita
- Long Beach Clinical Trial Services - Long Beach
- Provideré Research Inc. - West Covina
Florida
- Inpatient Research Clinic - Hialeah
- The Angel Medical Research Corporation - Miami Lakes
- Suncoast Clinical Research - Pasco County - New Port Richey
North Carolina
- Cary Medical Group - Cary
- Raleigh Medical Group - Raleigh
Texas
- ICON Early Phase Services - San Antonio
- Discovery Clinical Trials - Stone Oak - San Antonio
Pennsylvania
- Clinical Research of Philadelphia - Philadelphia
South Carolina
- Coastal Carolina Research Center - North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2023-07-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05312567
The ClinicalTrials.gov registry entry for NCT05312567 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,392-participant average among 54 other Menopause trials with a reported enrollment target (99% lower). The listed sponsor is Fervent Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Menopause appearing as the primary indexed condition, and to 1 intervention - of which FP-101 is the first listed.
NCT05312567 reports 12 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05312567 about?
NCT05312567 is a clinical study titled "FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms". This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101 (60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period of 1-week.
What is the current status of trial NCT05312567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2021-03-24. Estimated completion is 2023-07-31.
What conditions does trial NCT05312567 study?
This clinical trial studies the following conditions: Menopause, Vasomotor Symptoms.
What interventions are being tested in trial NCT05312567?
The interventions under investigation include: FP-101 (DRUG).
Who is sponsoring clinical trial NCT05312567?
This trial is sponsored by Fervent Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05312567 being conducted?
This trial has 12 study locations across California, Florida, North Carolina, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.