Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001259
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
1999-11-03
Brief Title:
A Treatment Study for Premenstrual Syndrome PMS
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Treatment of Menstrually-Related Mood Disorders With the Gonadotropin Releasing Hormone GnRH Agonist Depot Leuprolide Acetate Lupron
Status:
COMPLETED
Status Verified Date:
2021-01-04
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:
This study examines the effects of estrogen and progesterone on mood the stress response and brain function and behavior in women with premenstrual syndrome
Previously this study has demonstrated leuprolide acetate Lupron Registered Trademark to be an effective treatment for PMS The current purpose of this study is to evaluate how low levels of estrogen and progesterone that occur during treatment with leuprolide acetate compare to menstrual cycle levels of estrogen and progesterone given during individual months of hormone add-back on a variety of physiologic measures brain imaging stress testing etc in women with PMS
PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle luteal phase This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving in sequence the menstrual cycle hormones progesterone and estrogen The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS see also protocol 92-M-0174
At study entry participants will undergo a physical examination Blood urine and pregnancy tests will be performed Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies
Previously this study has demonstrated leuprolide acetate Lupron Registered Trademark to be an effective treatment for PMS The current purpose of this study is to evaluate how low levels of estrogen and progesterone that occur during treatment with leuprolide acetate compare to menstrual cycle levels of estrogen and progesterone given during individual months of hormone add-back on a variety of physiologic measures brain imaging stress testing etc in women with PMS
PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle luteal phase This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving in sequence the menstrual cycle hormones progesterone and estrogen The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS see also protocol 92-M-0174
At study entry participants will undergo a physical examination Blood urine and pregnancy tests will be performed Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies
Detailed Description:
This protocol is designed to accompany Clinical Protocol 81-M-0126 The Phenomenology and Biophysiology of Menstrually-Related Mood and Behavioral Disorders Its original purposes were as follows 1 to evaluate the efficacy of the gonadotropin releasing hormone GnRH agonist depot leuprolide acetate Lupron in the treatment of menstrually-related mood disorders MRMD by determining whether mood and behavioral symptoms are eliminated when the cyclic secretion of both gonadotropic hormones and gonadal steroids is suppressed and 2 to determine the possible relevance of gonadal steroids to affective state by sequentially replacing estradiol and progesterone during continued GnRH suppression in those patients whose premenstrual symptoms remit following administration of the GnRH agonist We observed that GnRH agonist induced ovarian suppression was an effective treatment compared to placebo in women with MRMD Additionally women with MRMD but not asymptomatic controls participating in companion protocol 92-M-0174 experienced a recurrence of mood and behavioral symptoms when either estradiol or progesterone but not placebo was added back These data suggest that women with MRMD have a differential sensitivity to the mood destabilizing effects of gonadal steroids
Having established that women with MRMD show a differential behavioral response to estrogen and progesterone we now hope to identify the underlying mechanisms and physiologic concomitants of the differential behavioral sensitivity by performing studies described in companion protocols under the three hormonal conditions created by this protocol and comparing results obtained with those seen in normal controls Protocol 92-M-0174 Planned studies include the following cognitive testing brain imaging 3D-positron emission tomography PET functional magnetic resonance imaging FMRI magnetic resonance spectroscopy MRS and genetic studies including induced pluripotent cells
Having established that women with MRMD show a differential behavioral response to estrogen and progesterone we now hope to identify the underlying mechanisms and physiologic concomitants of the differential behavioral sensitivity by performing studies described in companion protocols under the three hormonal conditions created by this protocol and comparing results obtained with those seen in normal controls Protocol 92-M-0174 Planned studies include the following cognitive testing brain imaging 3D-positron emission tomography PET functional magnetic resonance imaging FMRI magnetic resonance spectroscopy MRS and genetic studies including induced pluripotent cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 90-M-0088 | None | None | None |