FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms

NCT05312567 | Completed Phase 2 FDA Drug

• 1 other identifier: 2021-FERV
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 12

Brief 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

Vasomotor Symptoms; Menopause

Outcome Measures

Primary Outcomes (1)

• Change in the frequency (average daily number) of moderate-to-severe hot flashes.

  Subjects use a digital platform to record hot flash frequency in a daily eDiary.

  Recorded every 12 hrs over a 1-week treatment period.

Secondary Outcomes (3)

• Change in the severity (average daily rating) of moderate-to-severe hot flashes.

  Recorded every 12 hrs over a 1-week treatment period.

• Change in nighttime awakenings (average daily number) with or without night sweats.

  Recorded every morning over a 1-week treatment period.

• Evaluate the clinical meaningfulness of VMS changes after 1-week of treatment.

  After 1 week of treatment at the end-of-study visit.

Other Outcomes (1)

• Any Adverse Events and Concomitant Medications

  Recorded as needed/every 12 hrs over a 1-week treatment period.

Study Arms (2)

Active Treatment (FP-101)

EXPERIMENTAL

White to off-white extended-release, round tablets containing FP-101.

Drug: FP-101

Matching placebo

PLACEBO COMPARATOR

White to off-white round tablets without the active ingredient but otherwise matching in size and appearance.

Drug: FP-101

Interventions

FP-101 DRUG

daily oral tablet administration (b.i.d.)

Active Treatment (FP-101); Matching placebo

Eligibility Criteria

• Age: 46 Years+
• Gender Eligibility Details: Peri- and Post-menopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peri- and Post-Menopausal female subjects (\>45 yrs) experiencing a min of 7-8 moderate to severe hot flashes per day
• Able/willing to provide informed consent.
• Able/willing to complete all study procedures and visits.
• Able/willing to not use any over-the-counter (OTC) cough \& cold medications that contain the IMP active during the study.

You may not qualify if:

• Subject exhibits positive home pregnancy test at screening or any time during study
• Subject currently taking any form of Hormone Therapy (HT), including local estrogen therapies
• Subject currently taking tamoxifen, other selective estrogen receptor modulators, or other hormone deprivation therapy.
• Subject with history of serotonergic syndrome
• Subject is currently taking monoamine oxidase inhibitors (MAOIs) (or for 2 weeks after stopping the MAOI drug), antidepressants, thioridazine, pimozide, cannabidiol, opioids, antipsychotic agents, antiretroviral agents, quinidine, quinine, or other medications for VMS such as Brisdelle® (paroxetine mesylate), clonidine and gabapentin.
• Subject is currently taking a dietary/herbal supplement(s) to manage VMS, such as soy isoflavones or black cohosh.
• Subject has uncontrolled diabetes, a history of hypertension \& is not on a stable dose of antihypertensive medications for at least 30 days prior to screening.
• Subject has clinically unstable cardiac disease, including atrial fibrillation, symptomatic brady- or tachy-arrhythmias, congestive heart failure (NYHA class II, III, and IV), or symptomatic atherosclerotic cardiovascular disease (coronary artery disease, carotid artery disease or peripheral artery disease) or history of myocardial infarction or stroke within 2 years of enrolment in the study.
• Subject reports medical history suggestive of impaired liver/kidney function or, in the PI's opinion, exhibits liver/kidney function impairment to the extent that the subject should not participate in the study.
• Subject has biliary tract disease, adrenal cortical insufficiency, or any other medical condition that, in the PI's opinion (and after discussion with the medical monitor), is considered inadequately treated and precludes entry into the study.
• Subject has thyroid disease, unless subject is clinically stable with normal thyroid indices and is on maintenance thyroid medication (e.g., levothyroxine or liothyronine) for ≥6 months prior to screening.
• Subject has a history of, or is currently presenting with, substance use disorder as defined by the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Subject has a history of psychiatric disorders, including a lifetime history of major depressive disorder, bipolar disorder, panic disorder, generalized anxiety, psychotic disorders, suicidality or suicidal ideation, or post-traumatic stress disorder.
• Subject is currently participating in another clinical trial
• Subjects who were determined to be placebo responders or non-compliant during the 1-week run-in period.

Sponsors & Collaborators

• Fervent Pharmaceuticals: lead
• ICON plc: collaborator

Study Sites (12)

Torrance Clinical Research Institute

Lomita, California, 90717, United States

Location

Long Beach Clinical Trial Services

Long Beach, California, 90806, United States

Location

Provideré Research Inc.

West Covina, California, 91790, United States

Location

Inpatient Research Clinic

Hialeah, Florida, 33013, United States

Location

The Angel Medical Research Corporation

Miami Lakes, Florida, 33016, United States

Location

Suncoast Clinical Research - Pasco County

New Port Richey, Florida, 34652, United States

Location

Cary Medical Group

Cary, North Carolina, 27518, United States

Location

Raleigh Medical Group

Raleigh, North Carolina, 27609, United States

Location

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

Discovery Clinical Trials - Stone Oak

San Antonio, Texas, 78258, United States

Location

Study Officials

• Helmut H Albrecht, MD

  Lumanity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Matching placebo tablets. Double-blind treatment packaging and dispensation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, parallel-group, placebo-controlled study to compare patient-reported changes in VMS for the IMP vs. placebo. The study will be run as a fully decentralized clinical trial.

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: March 24, 2021
• Primary Completion: April 5, 2023
• Study Completion: July 31, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)