MenopausePhase 4NCT00225914
Study of Paxil Use in Menopausal Women
A Phase 4 study testing Paroxetine in people with Menopause, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women age 40 and above.
- 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).
- Women with prior use of HT for at least two months.
- Women who discontinued HT use 1 to 12 months prior to study entry (screening visit).
- 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).
- Women who report physical/emotional symptoms developing or worsening within 3 months of HT discontinuation.
- General good health.
Who cannot join
- Women who present with moderate-to-severe symptoms of depression (MADRS scores > 19) or anxiety (BAI scores > 19) at baseline.
- 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.
- 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.
- Suicidal ideation, homicidal ideation, or psychotic symptoms.
- Menstrual dysfunction and amenorrhea of other etiologies.
- History of seizure disorder
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Center for Perinatal and Women's Mental Health
Boston, Massachusetts, 02116
About this study
Official title: Paroxetine Controlled Release in the Treatment of Symptomatic Menopausal Women Following Discontinuation of Hormone Therapy
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.
Read the detailed 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.
- Conditions
- Menopause
- Being tested
- Paroxetine, placebo
- Keywords
- Menopause, Hormone Therapy, Paxil, Hot Flash, Sleep Disturbance, Night Sweats, Antidepressants
- Medical subject headings
- Hot Flashes, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
Also called Paxil
Paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability
placeboDrug
Subjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day or matching placebo pill; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability. Receives: Drug: Paroxetine |
| 2 | Placebo comparator | Subjects then enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day or matching placebo pill Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Visit 2 to Visit 4 in the daily hot flash frequency and severity. Response will be considered if ³50% reduction in the hot flash composite score-frequency X severity)
Measured: 6 weeks
Secondary outcomes (4)
Proportion of subjects with remission of menopause-related symptoms from Visit 2 to Visit 4 measured by a >50% decrease in Greene Climacteric Scale total and sub-scores and Hot Flush Related Daily Interference Scale (HFRDIS).
Measured: 6 weeks
Occurrence of discontinuation symptoms (DESS- Discontinuation Emergent Signs Symptoms, self-report) at Visit 4.
Measured: 6 weeks
Proportion of CGI responders (clinician-rated CGI- Improvement 2; Occurrence of adverse events (PRISE-Adverse Event Visit Checklist) throughout the study
Measured: 8 weeks
Proportion of subjects with remission of psychological symptoms (MADRS <10; BAI < 11 at Visit 4).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startSep 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Lee S. Cohen, M.D., Principal investigator, MGH Center for Perinatal and Women's Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225914
- Sponsor's protocol ID
- 2004-P-000115
- Status last verified
- Nov 2010
- First submitted
- 22 Sep 2005
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxetine Controlled Release in the Treatment of Symptomatic Menopausal Women Following Discontinuation of Hormone Therapy
- ClinicalTrials.gov ID
- NCT00225914
- Acronym / sponsor ID
- 2004-P-000115
- Conditions
- Menopause
- Keywords
- Menopause, Hormone Therapy, Paxil, Hot Flash, Sleep Disturbance, Night Sweats, Antidepressants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ParoxetineSubjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability. |
| 2 | Placebo comparator | Drug: placeboSubjects then enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day or matching placebo pill |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women age 40 and above.
- 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).
- Women with prior use of HT for at least two months.
- Women who discontinued HT use 1 to 12 months prior to study entry (screening visit).
- 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).
Key exclusion criteria (7 listed)
- Women who present with moderate-to-severe symptoms of depression (MADRS scores > 19) or anxiety (BAI scores > 19) at baseline.
- 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.
- 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.
- Suicidal ideation, homicidal ideation, or psychotic symptoms.
- Menstrual dysfunction and amenorrhea of other etiologies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParoxetineAlso: PaxilParoxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability | Drug | 1 |
| placeboSubjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day or matching placebo pill; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability. | Drug | 2 |
Primary outcome
Mean change from Visit 2 to Visit 4 in the daily hot flash frequency and severity. Response will be considered if ³50% reduction in the hot flash composite score-frequency X severity)
Time frame: 6 weeks
4 secondary outcomes
Proportion of subjects with remission of menopause-related symptoms from Visit 2 to Visit 4 measured by a >50% decrease in Greene Climacteric Scale total and sub-scores and Hot Flush Related Daily Interference Scale (HFRDIS).
Time frame: 6 weeks
Occurrence of discontinuation symptoms (DESS- Discontinuation Emergent Signs Symptoms, self-report) at Visit 4.
Time frame: 6 weeks
Proportion of CGI responders (clinician-rated CGI- Improvement 2; Occurrence of adverse events (PRISE-Adverse Event Visit Checklist) throughout the study
Time frame: 8 weeks
Proportion of subjects with remission of psychological symptoms (MADRS <10; BAI < 11 at Visit 4).
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2010.
- MGH Center for Perinatal and Women's Mental HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee S. Cohen, M.D. principal investigator
MGH Center for Perinatal and Women's Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paroxetine in people with Menopause, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from Visit 2 to Visit 4 in the daily hot flash frequency and severity. Response will be considered if ³50% reduction in the hot flash composite score-frequency X severity) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2010.