Study of Paxil Use in Menopausal Women

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: GlaxoSmithKline
• Treatments: Paroxetine

Criteria

Inclusion Criteria:

1. Women age 40 and above.

2. Perimenopausal status (defined as having cycles which vary by more than 7 days from normal, or 2 or more skipped cycles and an amenorrheic interval of at least 60 days but no more than 12 consecutive months) or postmenopausal status (defined as amenorrheic for 12 or more consecutive months).

3. Women with prior use of HT for at least two months.

4. Women who discontinued HT use 1 to 12 months prior to study entry (screening visit).

5. Women who present with significant menopause-related symptoms (defined as GCS total score >20; vasomotor sub-scores >3 and/or ³14 moderate to severe hot flashes per week), with or without concomitant psychological complaints (symptoms of depression and/or anxiety).

6. Women who report physical/emotional symptoms developing or worsening within 3 months of HT discontinuation.

7. General good health.

Exclusion Criteria:

1. Women who present with moderate-to-severe symptoms of depression (MADRS scores > 19) or anxiety (BAI scores > 19) at baseline.

2. Women who meet diagnostic criteria at screening visit for a current major Axis I psychiatric disorder other than specific phobias (assessed through M.I.N.I. interview). Subjects presenting with symptoms of anxiety or depression, but not meeting criteria for Depressive Disorders, Bipolar Disorder, Panic Disorder, GAD, OCD or SAD, will be allowed in the study.

3. Regular treatment with hormonal medications, SSRIs, tricyclic antidepressant, mood stabilizer, oral neuroleptics, sedatives or hypnotics, over-the-counter agents known to influence hot flushes or mood within 4 weeks prior to screening visit; used of depot neuroleptics within 12 weeks prior to screening visit.

4. Suicidal ideation, homicidal ideation, or psychotic symptoms.

5. Menstrual dysfunction and amenorrhea of other etiologies.

6. History of seizure disorder

7. Pregnancy or breastfeeding.