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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hot Flashes

In brief

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

Key facts

Study ID

NCT03285672

Run by

Fervent Pharmaceuticals

People needed

109

Starts

2018-03-26

Expected to finish

2018-10-29

Last updated by the study team

2018-11-01

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

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.
• Subject exhibits a positive urine pregnancy test result at screening or at any time during study

Where it is running

• 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

Full record on ClinicalTrials.gov

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