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

• ClinicalTrials.gov Identifier: NCT03285672
• Recruitment Status: Completed
• First Posted: September 18, 2017
• Last Update Posted: November 1, 2018
• Sponsor: Fervent Pharmaceuticals
• Collaborator: Iqvia Pty Ltd
• Information provided by (Responsible Party): Fervent Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hot Flashes	Drug: FP-101; Drug: Placebo Comparator	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-blind, Placebo Controlled, Single Dose-level, Proof-of-concept Study Evaluating FP-101 for the Treatment of Vasomotor Symptoms in Postmenopausal Women
• Actual Study Start Date: March 26, 2018
• Actual Primary Completion Date: October 29, 2018
• Actual Study Completion Date: October 29, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1; FP-101	Drug: FP-101; Dose 1
Placebo Comparator: Arm 2; Placebo Comparator	Drug: Placebo Comparator; Dose 1

Outcome Measures

Primary Outcome Measures :

1. The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes. [ Time Frame: Baseline to Week 8 ]

Secondary Outcome Measures :

1. Change in the severity of moderate-to-severe hot flashes. [ Time Frame: Baseline to Week 8 ]
2. Change in the severity of moderate-to-severe hot flashes. [ Time Frame: Baseline to Week 4 ]
3. Change in the frequency of moderate-to-severe hot flashes. [ Time Frame: Baseline to Week 4 ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

PMG Research of Christie Clinic, LLC

Champaign, Illinois, United States, 61820

United States, North Carolina

PMG Research of Cary, LLC

Cary, North Carolina, United States, 27518

PMG Research of Charlotte, LLC

Charlotte, North Carolina, United States, 28209

PMG Research of Hickory, LLC

Hickory, North Carolina, United States, 28601

PMG Research of Raleigh, LLC

Raleigh, North Carolina, United States, 27609

Nash OB/GYN

Rocky Mount, North Carolina, United States, 27804

PMG Research of Salisbury, LLC

Salisbury, North Carolina, United States, 28144

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States, 28401

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States, 27103

United States, South Carolina

PMG Research of Charleston, LLC

Mount Pleasant, South Carolina, United States, 29464

United States, Tennessee

PMG Research of Bristol, LLC

Bristol, Tennessee, United States, 37620

PMG Research of Knoxville

Oak Ridge, Tennessee, United States, 37830

Sponsors and Collaborators

Fervent Pharmaceuticals

Iqvia Pty Ltd

Investigators

• Study Director: George Raad; PMG Research of Charlotte, LLC

More Information

• Responsible Party: Fervent Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03285672
• Other Study ID Numbers: FERV001
• First Posted: September 18, 2017
• Last Update Posted: November 1, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fervent Pharmaceuticals:

Hot Flashes, vasomotor symptoms, postmenopausal

Additional relevant MeSH terms:

Hot Flashes