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PH80 Intranasal Spray for Acute Management of PMDD Symptoms
NCT01217775Phase 3
Key facts
- Status
- Unknown
- Start
- Mar 2016
- Primary completion
- Mar 2017
- Countries
- 1
- Sponsor
- Pherin Pharmaceuticals
- Modality
- Orthosteric Ligands
- Drugs
- refisolone
- Conditions
- Premenstrual Dysphoric Disorder (PMDD)
01
Overview
Phase 3, randomised, double-blind trial in Premenstrual Dysphoric Disorder (PMDD) comparing PH80 intranasal spray with Placebo intranasal spray (2 arms). Primary endpoint: Daily Record of Severity of Problems. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PH80 intranasal spray
PH80 800 nanograms intranasal spray
Placebo intranasal spray
Placebo intranasal spray
03
Who it enrols
Women aged 18-43 with regular menstrual cycles (22-35 days) and at least a 1-year history of PMDD. Excludes patients with major depressive disorder, bipolar depression, or significant systemic diseases.
04
Endpoints
Primary
Daily Record of Severity of Problems
Secondary
Patient Global Evaluation
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