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

NCT03285672 | Completed Phase 2 FDA Drug

• 1 other identifier: FERV001
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 12

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.

Conditions

Hot Flashes

Keywords

Hot Flashes, vasomotor symptoms, postmenopausal

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes.

  Baseline to Week 8

Secondary Outcomes (3)

• Change in the severity of moderate-to-severe hot flashes.

  Baseline to Week 8

• Change in the severity of moderate-to-severe hot flashes.

  Baseline to Week 4

• Change in the frequency of moderate-to-severe hot flashes.

  Baseline to Week 4

Study Arms (2)

Arm 1

EXPERIMENTAL

FP-101

Drug: FP-101

Arm 2

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo Comparator

Interventions

FP-101 DRUG

Dose 1

Arm 1

Placebo Comparator DRUG

Dose 1

Arm 2

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fervent Pharmaceuticals: lead
• Iqvia Pty Ltd: collaborator

Study Sites (12)

PMG Research of Christie Clinic, LLC

Champaign, Illinois, 61820, United States

Location

PMG Research of Cary, LLC

Cary, North Carolina, 27518, United States

Location

PMG Research of Charlotte, LLC

Charlotte, North Carolina, 28209, United States

Location

PMG Research of Hickory, LLC

Hickory, North Carolina, 28601, United States

Location

PMG Research of Raleigh, LLC

Raleigh, North Carolina, 27609, United States

Location

Nash OB/GYN

Rocky Mount, North Carolina, 27804, United States

Location

PMG Research of Salisbury, LLC

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

PMG Research of Charleston, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

PMG Research of Bristol, LLC

Bristol, Tennessee, 37620, United States

Location

PMG Research of Knoxville

Oak Ridge, Tennessee, 37830, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• George Raad

  PMG Research of Charlotte, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: March 26, 2018
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)