Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04478305
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2020-03-19
Brief Title:
Affect of Duavive on Mood Anxiety Symptoms
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
The Effect of Conjugated Estrogens Bazedoxifene CE BZA on Peri- and Postmenopausal Mood and Anxiety Symptoms A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOMA
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 CEBZA The study will last 16 weeks The studys objectives are to determine primarily if CEBZA improves mood among peri- and early postmenopausal women and secondarily if treatment with CEBZA improves their sleep
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 CEBZA The study will last 16 weeks The studys objectives are to determine primarily if CEBZA improves mood among peri- and early postmenopausal women and secondarily if treatment with CEBZA improves their sleep
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None