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

NCT01217775 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2015-12-03

No results posted yet for this study

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

Interventions

DRUG

PH80

PH80 intranasal spray 800 nanograms

DRUG

Placebo intranasal spray

Placebo intranasal spray

Sponsors & Collaborators

  • Pherin Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Ellen W Freeman, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2017-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217775 on ClinicalTrials.gov