Last updated: 11/07/2018 14:12:16
A Double-Blind, Placebo-Controlled, 3-Arm, Fixed-Dose Study of Paroxetine CR Continuous Treatment (12.5 mg/day and 25 mg/day) for Premenstrual Dysphoric Disorder
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Double-Blind, Placebo-Controlled, 3-Arm, Fixed-Dose Study of Paroxetine CR Continuous Treatment (12.5 mg/day and 25 mg/day) for Premenstrual Dysphoric Disorder
Trial description: A Double-Blind, Placebo-Controlled, 3-Arm, Fixed-Dose Study of Paroxetine CR Continuous Treatment (12.5 mg/day and 25 mg/day) for Premenstrual Dysphoric Disorder
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Paroxetine controlled release is effective in treating premenstrual dysphoric disorder: a pooled analysis of three trials. Yonkers, Kimberly A. MD, Hunter, Brian N. PhD, Bellew, Kevin M. MS, Rolfe, Timothy E. MSc, Steiner, Meir MD PhD, and Heller, Vicki L. MD 51st Annual Clinical Meeting of the American College of Obstetricians and Gynecologists 4/26/2003 New Orleans, LA; USA
Pooled analysis of three large clinical trials in the treatment of pmdd. Yonkers, Kimberly A. M. D., Bellew, Kevin M. M. S., Rolfe, Timothy E. M. Sc., and Perera, Philip M. D. 156th Annual Meeting of the American Psychiatric Association 5/17/2003 San Francisco, CA; USA
Pooled analysis of three multi-centre double-blind placebo-controlled clinical trials with paroxetine controlled-release (cr) in the treatment of premenstrual dysphoric disorder. Hunter, Brian, Bellew, Kevin M, and Perera, Philip D International Congress of the World Federation of Biological Psychiatry 2/9/2004 Sydney; Australia
Yonkers KA. Paroxetine treatment of mood disorders in women: premenstrual dysphoric disorder and hot flashes. Psychopharmacol Bull. 2003 Spring;37 Suppl 1:135-47.
Medical condition
Premenstrual Syndrome
Product
paroxetine
Collaborators
Not applicable
Study date(s)
November 1999 to January 2002
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-14-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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