Clinical Trial: Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 3 Study of the Use of PH80 for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder

Brief Summary: The objective of this study is to evaluate the effectiveness and safety in double-blind, randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for the acute management of cycle related symptoms in women who regularly experience premenstrual dysphoric disorder (PMDD).

Detailed Summary:

Premenstrual disorders are characterized by negative mood, behavioral, and physical symptoms that occur consistently for several days to two weeks before menses, that can disrupt normal functioning, and that subside during the postmenstrual phase of the cycle. Marked irritability, marked depressed mood, marked anxiety, overeating of specific food cravings, mood swings, lack of energy, and pain are among the most common symptoms of moderate to severe premenstrual disorders.

It is estimated that 75% women of reproductive age (menarche to perimenopause) experience physical and behavioral symptoms premenstrually and in 40% women symptoms are intense (moderate to severe) and require medical attention. For 3-8 % women premenstrual symptoms are severe enough to interfere with work and interpersonal relationships. Premenstrual Dysphoric Disorder (PMDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) research criteria, represents the more severe and disabling end of the premenstrual disorders spectrum. For women with severe premenstrual symptoms or PMDD, these symptoms are bothersome enough to produce an impact on psychological and/or occupational functioning, and professional attention is required.

Selective serotonin reuptake inhibitors (SSRIs) fluoxetine, sertaline and paroxetine have been approved by the United States Food and Drug Administration (FDA) as a chronic treatment for PMDD, however the use of SSRIs significantly increases the risk of suicide in adolescents and young adults. Antidepressants are also associated with significant relapse during short and long term treatment of PMDD. Contraceptives are also prescribed to treat moderate and severe premenstrual symptoms, but besides the severe adverse effects (drospirenone and ethinyl estradiol) they re not the treatment choi
Sponsor: Pherin Pharmaceuticals, Inc.

Current Primary Outcome: Daily Record of Severity of Problems (DRSP)scores [ Time Frame: Daily DRSP sores ]

Primary outcome meassure: difference between average luteal phase DRSP total scores from 2 qualification cycles and average luteal phase DRSP socores from 6 treatment cycles.


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient Global Evaluation (PGE) [ Time Frame: Daily PGE scores ]

Secondary outcome measures include: each of the 11 individual items of the DRSP, scheduled patient and Investigator global evaluations of the patients' PMDD symptoms, including patient-rated Global Evaluations (PGE) and Investigator rated Clinical Global Impression (CGI) ratings.


Original Secondary Outcome: Same as current

Information By: Pherin Pharmaceuticals, Inc.

Dates:
Date Received: October 7, 2010
Date Started: March 2016
Date Completion: July 2017
Last Updated: December 1, 2015
Last Verified: December 2015