FP-101 for the Treatment of Hot Flashes in Postmenopausal Women

NCT ID: NCT03285672

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-26
• Study Completion Date: 2018-10-29

Brief Summary

The purpose of the study is to determine the efficacy of FP-101 versus placebo for the treatment of hot flashes in postmenopausal women.

Detailed Description

Vasomotor symptoms, commonly known as hot flashes or hot flushes, are the most common symptoms experienced by women who are perimenopausal or postmenopausal. FP-101 is postulated to mediate one of the mechanisms thought to drive hot flashes in post-menopausal women. This study will evaluate the efficacy and safety of FP-101 for the treatment of hot flashes in post-menopausal women.

Conditions

Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

FP-101

Group Type: EXPERIMENTAL

FP-101

Intervention Type: DRUG

Dose 1

Arm 2

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: DRUG

Dose 1

Interventions

FP-101

Dose 1

Intervention Type: DRUG

Placebo Comparator

Dose 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects may be enrolled in the main study only if they meet all of the following criteria:

• Subject must be a female >40 years of age at screening.
• Subject must have reported more than 7 to 8 moderate-to-severe hot flashes per day or 50 to 60 hot flashes per week for at least 30 days prior to the Screening Visit of sufficient severity to cause desire for therapeutic intervention.
• Subject must meet 1 of the following criteria:

• Spontaneous amenorrhea for at least 12 consecutive months.
• Amenorrhea for at least 6 months and meet the biochemical criteria for menopause (FSH ≥40 mIU/mL).
• Bilateral oophorectomy or salpingo-oophorectomy ≥6 weeks prior to enrollment with or without hysterectomy.
• A subject who is not at least 2 years postmenopausal must use adequate nonhormonal contraception (eg, barrier methods such as an intrauterine device, diaphragm, cervical cap, or condom) during study participation.
• Subject must be willing and able to be compliant with the protocol and provide a voluntary written informed consent.

Exclusion Criteria

• Subject has a history of hypersensitivity or adverse reaction to FP-101 or its excipients
• Subject is a known non-responder to previous SSRI or SNRI treatment for VMS
• Subject has a history of self-injurious behavior.
• Subject has a lifetime history of a clinical diagnosis of major depression or treatment for major depressive disorder.
• Subject has a history of clinical diagnosis of borderline personality disorder.
• 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 (DSM-5).
• 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 has a history of hypertension and is not on a stable dose of antihypertensive medications for at least 30 days prior to screening.
• Subject is currently taking MAOIs, thioridazine, or pimozide.
• Subject is currently taking tamoxifen, other selective estrogen receptor modulators, or other hormone deprivation therapy.
• Subject exhibits evidence of impaired liver function upon entry into the study (values ≥2 times the upper limit of normal for aspartate transaminase and/or alanine transaminase, or serum bilirubin ≥1.3 mg/dL) or, in the Investigator's opinion, exhibits liver function impairment to the extent that the subject should not participate in the study.
• Subject has clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia.
• Subject exhibits evidence of impaired kidney function upon entry into the study (i.e., serum creatinine >1.5 mg/dL) or known renal stricture.
• Subject has biliary tract disease, adrenal cortical insufficiency, or any other medical condition that, in the Investigator's opinion, is 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 exhibits a positive urine pregnancy test result at screening or at any time during study

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Fervent Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Raad

Role: STUDY_DIRECTOR

PMG Research of Charlotte, LLC

Locations

PMG Research of Christie Clinic, LLC

Champaign, Illinois, United States

PMG Research of Cary, LLC

Cary, North Carolina, United States

PMG Research of Charlotte, LLC

Charlotte, North Carolina, United States

PMG Research of Hickory, LLC

Hickory, North Carolina, United States

PMG Research of Raleigh, LLC

Raleigh, North Carolina, United States

Nash OB/GYN

Rocky Mount, North Carolina, United States

PMG Research of Salisbury, LLC

Salisbury, North Carolina, United States

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

PMG Research of Charleston, LLC

Mt. Pleasant, South Carolina, United States

PMG Research of Bristol, LLC

Bristol, Tennessee, United States

PMG Research of Knoxville

Oak Ridge, Tennessee, United States

Countries

United States

Other Identifiers

FERV001

Identifier Type: -

Identifier Source: org_study_id