drugset / Trial / NCT01217775

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

NCT01217775 ↗

Phase 3 Unknown 1400 enrolled Pherin Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

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

Publications

  • Background 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.

Drugs

EvaluationDrugModalityDoseRoute
Subject PH80 Other / unclassified 800 ng Intranasal