Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001770
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Progestin Progesterone-Like Hormones Induced Dysphoria Depressed Mood Irritability Anxiety
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Phenomenology and Biophysiology of Progestin-Induced Dysphoria
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
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:
None
Brief Summary:
Often women are prescribed hormone replacement therapy HRT during the perimenopause or menopause
Hormone replacement therapy includes both estrogen and progesterone The estrogen component of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones but estrogen also increases the risk of uterine cancer The progesterone component of the HRT progestin works to prevent the increased risk of uterine cancer
There is evidence that some women experience unpleasant mood symptoms such as irritability depressed mood and anxiety while receiving hormone replacement therapy HRT while taking the progestin progesterone component of the HRT
This study is designed to evaluate the ability of progestins to produce negative mood symptoms in women Researchers intend on doing this by comparing the effects of medroxyprogesterone acetate Provera and a placebo inactive sugar pill Patients moods will be monitered based on their response to questionnaires answered in the outpatient clinic and at home
This research will attempt to answer the following questions
1 Are progestins associated with changes in mood during hormone replacement therapy
2 If progestins are associated with mood disturbance is it because they are blocking the beneficial effects of estrogen
Hormone replacement therapy includes both estrogen and progesterone The estrogen component of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones but estrogen also increases the risk of uterine cancer The progesterone component of the HRT progestin works to prevent the increased risk of uterine cancer
There is evidence that some women experience unpleasant mood symptoms such as irritability depressed mood and anxiety while receiving hormone replacement therapy HRT while taking the progestin progesterone component of the HRT
This study is designed to evaluate the ability of progestins to produce negative mood symptoms in women Researchers intend on doing this by comparing the effects of medroxyprogesterone acetate Provera and a placebo inactive sugar pill Patients moods will be monitered based on their response to questionnaires answered in the outpatient clinic and at home
This research will attempt to answer the following questions
1 Are progestins associated with changes in mood during hormone replacement therapy
2 If progestins are associated with mood disturbance is it because they are blocking the beneficial effects of estrogen
Detailed Description:
There is evidence in the literature that some women experience dysphoric symptoms while receiving hormone replacement therapy HRT and that this disturbance in mood is related to the progestin component of the HRT The bulk of this evidence is anecdotal While some authors have attempted to examine this putative problem in a more systematic fashion there are no controlled studies that attempt to identify the mechanism through which the perturbation in mood occurs Adverse effects of progestins might be mediated directly through the progesterone or androgen receptor Alternatively the effects of progestins might be consequent to the antiestrogen effects of progesterone This latter possibility is in part supported by our observation in previous studies of the beneficial effects of estradiol on mood and the possible precipitation of mood disturbance following acute estrogen withdrawal Finally despite the popular lore that progesterone causes mood disturbances a placebo effect cannot be ruled out since women taking HRT know when they are receiving the progestin component of the regimen Our research questions therefore are as follows 1 Are progestins associated with changes in mood during HRT and 2 If progestins are associated with mood disturbance is it because they are blocking the beneficial effects of estrogen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-M-0079 | None | None | None |