Clinical trial NCT05312567: FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vasomotor Symptoms
Menopause
Lead sponsor: Fervent Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2022-04-05
Enrollment: 105
Sex: FEMALE
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: This randomized, double-blind, parallel-group, placebo-controlled, clinical trial is designed to compare patient-reported changes in Vasomotor Symptoms (VMS) for FP-101 vs. placebo in peri- and post-menopausal women. The study will be run as a fully decentralized clinical trial (DCT), by use of components such as electronic Consent (eConsent), mobile/tele health visits, electronic Patient Reported Outcomes (ePROs), and direct-to-participant shipping of the (investigational medicinal product (IMP). The DCT approach to this study will rely on a digital platform through which subjects can consent, enroll, and interact with the PI and study staff. Proper regulatory framework and technology use will ensure compliance with Good Clinical Practice (GCP), ethics \& legal/regulatory requirements.

Healthy peri- and post-menopausal women (\>45 years of age) suffering from VMS will be recruited if they have \>=7- 8 moderate to severe hot flushes per day at baseline. After meeting all eligibility criteria subjects will be enrolled and start a 1-week run-in period to identify/eliminate placebo responders, as well as to exclude subjects who have difficulty completing the eDiary. Any Adverse Events (AEs) during the run-in period will serve as baseline for the safety assessments at the end of the treatment period.

Eligible subjects will undergo a tele health baseline visit during which the criteria for inclusion in the treatment period will be confirmed. Over a 1-week treatment period, subjects will complete a daily electronic Diary (eDiary) to record any AEs and the frequency and severity of hot flashes during the past 12hr interval. In the morning, subjects will record the number of awakenings during the past night and the number of night sweats.

The PI will conduct an end-of-study visit with each of the subjects randomized to the study medications to review safety and efficacy data, complete a Patient Global Improvement Scale, and clarify any open issues with the subjects.

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Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the frequency (average daily number) of moderate-to-severe hot flashes.
timeFrame: Recorded every 12 hrs over a 1-week treatment period.
Secondary outcomes:
measure: Change in the severity (average daily rating) of moderate-to-severe hot flashes.
timeFrame: Recorded every 12 hrs over a 1-week treatment period.
measure: Change in nighttime awakenings (average daily number) with or without night sweats.
timeFrame: Recorded every morning over a 1-week treatment period.
measure: Evaluate the clinical meaningfulness of VMS changes after 1-week of treatment.
timeFrame: After 1 week of treatment at the end-of-study visit.
Other outcomes:
measure: Any Adverse Events and Concomitant Medications
timeFrame: Recorded as needed/every 12 hrs over a 1-week treatment period.
Locations:
city: Lomita
country: United States
facility: Torrance Clinical Research Institute
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trial Services
state: California
city: West Covina
country: United States
facility: Provideré Research Inc.
state: California
city: Hialeah
country: United States
facility: Inpatient Research Clinic
state: Florida
city: Miami Lakes
country: United States
facility: The Angel Medical Research Corporation
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research - Pasco County
state: Florida
city: Cary
country: United States
facility: Cary Medical Group
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Medical Group
state: North Carolina
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials - Stone Oak
state: Texas
Study officials:
affiliation: Lumanity
name: Helmut H Albrecht, MD
role: STUDY_DIRECTOR
References: