FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
Public ClinicalTrials.gov record NCT05312567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-Blind, Plac.-Controlled Clinical Study to Compare the Efficacy of FP-101 60mg b.i.d. vs. Placebo for the Treatment of Moderate-to-Severe Hot Flashes in Peri- and Post-menopausal Women Over a Period of 1-Week.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05312567
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 46 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 24, 2021 (Actual)
- Primary completion
- Apr 5, 2023 (Actual)
- Completion
- Jul 31, 2023 (Actual)
- Last update posted
- Oct 26, 2023
2021 – 2023
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Torrance Clinical Research Institute | Lomita | California | 90717 | — |
| Long Beach Clinical Trial Services | Long Beach | California | 90806 | — |
| Provideré Research Inc. | West Covina | California | 91790 | — |
| Inpatient Research Clinic | Hialeah | Florida | 33013 | — |
| The Angel Medical Research Corporation | Miami Lakes | Florida | 33016 | — |
| Suncoast Clinical Research - Pasco County | New Port Richey | Florida | 34652 | — |
| Cary Medical Group | Cary | North Carolina | 27518 | — |
| Raleigh Medical Group | Raleigh | North Carolina | 27609 | — |
| Clinical Research of Philadelphia | Philadelphia | Pennsylvania | 19114 | — |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | — |
| ICON Early Phase Services | San Antonio | Texas | 78209 | — |
| Discovery Clinical Trials - Stone Oak | San Antonio | Texas | 78258 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05312567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2023 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05312567 live on ClinicalTrials.gov.