drugset / Trial / NCT01217775
Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PH80 | Other / unclassified | 800 ng | Intranasal |