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

NCT01217775 | Unknown Phase 3 DMC

• 1 other identifier: PH80 CL019
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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).

Conditions

Premenstrual Dysphoric Disorder

Keywords

PMDD, Premenstrual, Dysphoria, Mood Swings, Bloating.

Outcome Measures

Primary Outcomes (1)

• Daily Record of Severity of Problems (DRSP)scores

  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.

  Daily DRSP sores

Secondary Outcomes (1)

• Patient Global Evaluation (PGE)

  Daily PGE scores

Study Arms (2)

PH80 intranasal spray

EXPERIMENTAL

Start using study medication on 14th of the cycle, or the day symptoms start to bother, or if no symptoms on day 21st of the cycle but no later than day 21st of the cycle, up to 6-times per day, and continuing until day 2-3 of the menses

Drug: PH80

Placebo intranasal spray

PLACEBO COMPARATOR

Start using study medication on 14th of the cycle, or the day symptoms start to bother, or if no symptoms on day 21st of the cycle but no later than day 21st of the cycle, up to 6-times per day, and continuing until day 2-3 of the menses

Drug: Placebo intranasal spray

Interventions

PH80 DRUG

PH80 intranasal spray 800 nanograms

PH80 intranasal spray

Placebo intranasal spray DRUG

Placebo intranasal spray

Placebo intranasal spray

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pherin Pharmaceuticals, Inc.: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Freeman, Ellen W. and Monti, Louis. Evaluation of a unique low dose intranasal aerosol for the treatment of clinically significant premenstrual symptomes NCDEU (New Clinical Drug Evaluation Unit)47th Annual Meeting,June 2007.

  BACKGROUND

Related Links

• educational webpage about premenstrual symptoms and PMDD

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ellen W Freeman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen W. Freeman, Ph.D.

CONTACT

215-662-3329; fremane@mail.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)