NCT01217775

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Pherin Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

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 description

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 choice for women willing to become pregnant. Pherin Pharmaceuticals synthesized a number of pherines and screened them for biologic activity in vitro. PH80 is a pherine shown to bind to a subset of peripheral receptors in nasal chemosensory neurons. Pherines such as PH80 are thought to exert their activity by rapid stimulation of the hypothalamus, which does not require systemic uptake and distribution. PH80 is being investigated as a potential treatment in women that suffer the cycle related symptoms of Premenstrual Dysphoric Disorder. Each single administration of PH80 to be tested in this study will deliver a similar amount of PH80 (800 nanogram) to the nasal passages as was found in previous investigations (Pherin Clinical Study #PH80 CL003, #PH80 CL015 and #PH80 CL016) to improve premenstrual symptoms in PMDD patients when administered intranasally on an acute basis.

Conditions

• Premenstrual Dysphoric Disorder

Interventions

Type	Name	Description
DRUG	PH80	PH80 intranasal spray 800 nanograms
DRUG	Placebo intranasal spray	Placebo intranasal spray

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-03-01
• Completion: 2017-07-01
• First posted: 2010-10-08
• Last updated: 2015-12-03

Locations

1 site across 1 country: United States