ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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905-521-2100
Adult Trials: 18+ Years
- 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)
- 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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| 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 |
| ||||||||
| 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 | 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:
Exclusion Criteria:
| ||||||||
| Sex/Gender ICMJE |
| ||||||||
| Ages ICMJE | 45 Years to 60 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
| ||||||||
| 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 |
| ||||||||
| IPD Sharing Statement ICMJE |
| ||||||||
| Responsible Party | Alison Shea, St. Joseph's Healthcare Hamilton | ||||||||
| Study Sponsor ICMJE | St. Joseph's Healthcare Hamilton | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | St. Joseph's Healthcare Hamilton | ||||||||
| Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||