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

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pherin Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Female, age 18 to 43 years, with regular menstrual cycles between 22 - 35 days in length inclusive.

• Women of childbearing potential may participate if they are not pregnant or breast feeding, and if they agree to use one of the following methods of contraception throughout the study: abstinence, intrauterine device, condom and foam, diaphragm and spermicide, vasectomy and spermicide, tubal ligation and spermicide, oral contraceptives and barrier method. Women using oral contraceptives must have been on a stable dosing regimen for at least 6 months prior to study entry and must agree to continue on that same dosing regimen throughout all phases of the study.

• Patients who reported at least a 1-year history of regularly experiencing PMDD.

• Patients who are able to read and understand the Informed Consent document; are willing and able to comply with the protocol; and who had read, understood, and voluntarily signed the written Informed Consent prior to the performance of any study-specific procedures.

Exclusion Criteria:

• Patients who fail to meet the study criteria for PMDD

• Patients with active diabetes mellitus, neurological, cardiac, renal, hepatic, or pulmonary disease, or with any other significant medical or gynecological abnormality or condition, as determined by physical examinations and/or clinical laboratory tests.

• Patients diagnosed with Major Depressive Disorder or Bipolar Depression.

• Patients with an acute or chronic condition that at the judgment of the clinical Investigator could harm the patient and/or alter the outcome of the study. Additional clinical examinations and symptom assessment will be performed at this time to determine continuing eligibility for study participation.

• Patients who used any intranasal medication other than study drug within 14 days prior to study entry and/or during the Run-In and/or Treatment Phases of the study.

• Patients with other clinical conditions or diseases, or those who were taking concomitant medications, which in the clinical judgment of the Investigator could place the patient at undue risk, interfere with study participation, or confound the results of the study.

• Patients with current or last 2 years history of substance abuse.

• Patients who had a positive urine drug screen for any of the following: amphetamines, barbiturates, cocaine metabolites, opiates, benzodiazepines, and/or cannabinoids.

• Patients who had been treated previously with PH80.

• Patients who had participated in another research study or received another investigational drug within 30 days prior to study entry or during the study.

• Patients who used any other exclusionary prescription and/or nonprescription medications as specified in the study protocol (described in this report) within 14 days prior to study entry and/or during the Run-In and/or Treatment Phases of the study.