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PH80 intranasal spray for Premenstrual Dysphoric Disorder (PH80-PMD Trial)
Phase 3
Waitlist Available
Led By Ellen W Freeman, PhD
Research Sponsored by Pherin Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily pge scores
Awards & highlights
PH80-PMD Trial 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).
PH80-PMD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily drsp sores
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily drsp sores
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily Record of Severity of Problems (DRSP)scores
Secondary outcome measures
Patient Global Evaluation (PGE)
PH80-PMD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PH80 intranasal sprayExperimental Treatment1 Intervention
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
Group II: Placebo intranasal sprayPlacebo Group1 Intervention
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
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Who is running the clinical trial?
Pherin Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
113 Total Patients Enrolled
Ellen W Freeman, PhDPrincipal InvestigatorUniversity of Pennsylvania
4 Previous Clinical Trials
754 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Ontario
California
New York
Other
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
Why did patients apply to this trial?
Anything I can do to help find a solution for PMDD. Mine’s been wreaking havoc on my life and loved ones, I feel like a werewolf each month right before my period. I’m willing to try Anything to help manage it.
PatientReceived 1 prior treatment
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