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NCT01829919 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
A Phase 1 study of Postmenopausal Symptoms, sponsored by Noven Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01829919: Completed Phase 1 study of Postmenopausal Symptoms, sponsored by Noven Therapeutics.
NCT01829919 is a Phase 1 study of Postmenopausal Symptoms that has completed, run by Noven Therapeutics. The registered enrollment target is 24 participants, below the 94-participant average among 7 other Postmenopausal Symptoms trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01829919, a Phase 1 study of Postmenopausal Symptoms, has completed, sponsored by Noven Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate) Capsules 7.5 mg when given as a single dose and multiple doses.
Conditions Studied
Interventions
- DRUG Brisdelle (paroxetine mesylate)
Study Locations (1)
Maryland
- SNBL Clinical Pharmacology Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT01829919 record still lists
NCT01829919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 94-participant average among 7 other Postmenopausal Symptoms trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Postmenopausal Symptoms appearing as the primary indexed condition, and to 1 intervention - of which Brisdelle (paroxetine mesylate) is the first listed.
NCT01829919 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01829919 about?
NCT01829919 is a clinical study titled "Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women". The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate) Capsules 7.5 mg when given as a single dose and multiple doses.
What is the current status of trial NCT01829919?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-07. Estimated completion is 2011-08.
What conditions does trial NCT01829919 study?
This clinical trial studies the following conditions: Postmenopausal Symptoms.
What interventions are being tested in trial NCT01829919?
The interventions under investigation include: Brisdelle (paroxetine mesylate) (DRUG).
Who is sponsoring clinical trial NCT01829919?
This trial is sponsored by Noven Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01829919 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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