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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: Completed Phase 2 study of Menopause and Vasomotor Symptoms, sponsored by Fervent Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subjects use a digital platform to record hot flash frequency in a daily eDiary.
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 |
What the finished NCT05312567 record still lists
NCT05312567 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 9,392-participant average among 54 other Menopause trials with a reported enrollment target (99% lower).
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 lists 12 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Menopause
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05312567's enrollment target sits among peer trials
105 17th of 54 higher than 38 of 54 other Menopause trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menopause trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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