Study of Paxil Use in Menopausal Women

Status Completed

Clinical Trial Summary

To evaluate the efficacy, safety, and tolerability of Paroxetine treatment in perimenopausal and postmenopausal women who present with menopause-related symptoms after discontinuing hormone therapy (HT), in the presence or absence of concomitant symptoms of depression or anxiety.

Clinical Trial Description

This study is a 10-week double-blinded treatment study of perimenopausal and postmenopausal women who present with menopause-related symptoms after discontinuing Hormone Therapy(HT), with or without concomitant symptoms of depression and anxiety.

The menopausal transition is a period of heightened vulnerability to mood and anxiety disturbances. It is also a period when women may experience significant vasomotor symptoms (i.e. hot flushes and night sweats). More recently, the occurrence of vasomotor symptoms has been associated with increased risk for depression in menopausal women.

The efficacy of estrogens for the treatment of vasomotor symptoms is well established. In addition, the literature support a modulatory effect exerted by estrogen on various neurotransmitter systems that regulate mood and anxiety.

Despite the efficacy of hormone therapy (HT) for the treatment of menopause-related symptoms, a significant number of women discontinue its use during the first year of treatment. Moreover, recent findings from the Women's Health Initiative Study (WHI) have challenged the safety and the benefits that were initially thought to be associated with long-term use of HT. As a result, many women who have been taking HT decided to discontinue the use of HT, which may result in significant changes in their physical well being, quality of life and, possibly, their mental health status. Therefore, the efficacy and tolerability of other interventions such as antidepressants for these sub-populations warrant further investigation.

Treatment with Paroxetine has shown to be efficacious for menopause-related vasomotor symptoms. To date, no studies have examined the extent to which SSRIs may improve physical and psychological symptoms in women who discontinued HT. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Menopause

Clinical Trial Details

NCT number	NCT00225914
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	September 2004
Completion date	September 2006

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.