Affect of Duavive on Mood & Anxiety Symptoms

NCT04478305

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Menopause, Anxiety Depression, Sleep
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Females between 45-60 years of age

- Able to communicate in English

- In perimenopause as defined by World Health Organization (WHO) STages of Reproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final menstrual period)

- Suffering from Depressive symptoms (16+ on CES-D) AND/OR anxiety symptoms (10+ on GAD-7)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia.


- Abnormal uterine bleeding that has not been adequately investigated.


- Active or past venous or arterial thromboembolic disease (deep vein thrombosis,
pulmonary embolism, stroke, myocardial infarction, coronary heart disease).


- Active liver disease.


- Known protein C, protein S, or antithrombin deficiency or other known thrombophilic
disorders.


- Known or suspected pregnancy, women who may become pregnant, and nursing mothers


- Partial or complete loss of vision due to ophthalmic vascular disease.


- Uncontrolled hypertension (Systolic blood pressure >160mm Hg and/ or diastolic blood
pressure >95 mm Hg)


- Other endocrine disease that may adversely affect mood: uncontrolled thyroid disease,
Cushing's disease, Addison's disease, hyperparathyroidism. For women with abnormal
thyroid stimulating hormone (TSH), it will be corrected in advance of trial
initiation.


- Active serious suicidal ideation with intent.


- Regular treatment with a selective serotonin reuptake inhibitor or
serotonin-norepinephrine reuptake inhibitor within 2 months before screening visit


- Use of other psychoactive or centrally acting medications within 2 weeks before study
screening


- Known hypersensitivity to either CE or BZA.

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Menopause, Anxiety Depression, SleepAffect of Duavive on Mood & Anxiety Symptoms
NCT04478305
Female
45 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Affect of Duavive on Mood & Anxiety Symptoms
Official Title  ICMJE The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study
Brief Summary This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.
Detailed Description

During the transition to menopause, women are at risk for developing symptoms of depression and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in this. The investigators suspect that the administration of estrogens without progesterone, such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada, but the effect on mood were not examined closely.

The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently seeking treatment for symptoms of depression or anxiety. The participants will go through a round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and secondarily if treatment with CE/BZA improves their sleep.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single group longitudinal study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Menopause
  • Depression, Anxiety
  • Sleep
Intervention  ICMJE Drug: Duavive 0.45Mg-20Mg Tablet
Duavee, marketed as Duavive in Canada.
Other Name: Duavive
Study Arms  ICMJE Intervention group
Patient will be provided with study medication. To be taken once a day for 16 weeks (112 days). Active drug brand name - Duavive/Duavee. Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.
Intervention: Drug: Duavive 0.45Mg-20Mg Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females between 45-60 years of age
  • Able to communicate in English
  • In perimenopause as defined by World Health Organization (WHO) STages of Reproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final menstrual period)
  • Suffering from Depressive symptoms (16+ on CES-D) AND/OR anxiety symptoms (10+ on GAD-7)

Exclusion Criteria:

  • Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia.
  • Abnormal uterine bleeding that has not been adequately investigated.
  • Active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease).
  • Active liver disease.
  • Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.
  • Known or suspected pregnancy, women who may become pregnant, and nursing mothers
  • Partial or complete loss of vision due to ophthalmic vascular disease.
  • Uncontrolled hypertension (Systolic blood pressure >160mm Hg and/ or diastolic blood pressure >95 mm Hg)
  • Other endocrine disease that may adversely affect mood: uncontrolled thyroid disease, Cushing's disease, Addison's disease, hyperparathyroidism. For women with abnormal thyroid stimulating hormone (TSH), it will be corrected in advance of trial initiation.
  • Active serious suicidal ideation with intent.
  • Regular treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor within 2 months before screening visit
  • Use of other psychoactive or centrally acting medications within 2 weeks before study screening
  • Known hypersensitivity to either CE or BZA.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alison Shea, MD905-521-2100 ext 33973[email protected]
Contact: Sophie Vincent, MD[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04478305
Other Study ID Numbers  ICMJE 2019-7333
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Alison Shea, St. Joseph's Healthcare Hamilton
Study Sponsor  ICMJE St. Joseph's Healthcare Hamilton
Collaborators  ICMJE
  • McMaster University
  • Pfizer
Investigators  ICMJE
Principal Investigator:Alison Shea, MDSt. Joseph's Healthcare, McMaster University
PRS Account St. Joseph's Healthcare Hamilton
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP