Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005011
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2000-03-29
Brief Title:
Combined Hormone Replacement in Menstrually-Related Mood Disorders
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 Continuous Gonadal Steroid Replacement
Status:
COMPLETED
Status Verified Date:
2016-10-28
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 investigates the effects on symptoms of combined treatment with estrogen and progesterone in women with severe premenstrual syndrome PMDD
Studies indicate that women with PMS experience improvement in symptoms following treatment with leuprolide acetate when estrogen and progesterone levels are low Women with PMS but not women without the disorder experience a return of symptoms within approximately a week after re-exposure to either estrogen or progesterone The cause of this hormone-induced depression remains unclear It is not known whether this depressed mood is due simply to the change in the levels of estrogen and progesterone and whether it would remit following continued exposure to stable levels of estrogen and progesterone This study will determine whether the maintenance of stable hormone levels will prevent mood disturbances in women with PMS
Participants in this study will receive leuprolide acetate injections once a month for up to 6 months After 2 months women whose symptoms have improved will receive a skin patch containing either estrogen or placebo an inactive substance and will be asked to take daily suppositories containing either progesterone or placebo Women whose symptoms of PMS do not respond to leuprolide treatment after 2 months will end the study and be offered other treatment Participants will be seen by a nurse in the clinic every two weeks and will fill out ratings and have blood drawn to measure hormone levels
Studies indicate that women with PMS experience improvement in symptoms following treatment with leuprolide acetate when estrogen and progesterone levels are low Women with PMS but not women without the disorder experience a return of symptoms within approximately a week after re-exposure to either estrogen or progesterone The cause of this hormone-induced depression remains unclear It is not known whether this depressed mood is due simply to the change in the levels of estrogen and progesterone and whether it would remit following continued exposure to stable levels of estrogen and progesterone This study will determine whether the maintenance of stable hormone levels will prevent mood disturbances in women with PMS
Participants in this study will receive leuprolide acetate injections once a month for up to 6 months After 2 months women whose symptoms have improved will receive a skin patch containing either estrogen or placebo an inactive substance and will be asked to take daily suppositories containing either progesterone or placebo Women whose symptoms of PMS do not respond to leuprolide treatment after 2 months will end the study and be offered other treatment Participants will be seen by a nurse in the clinic every two weeks and will fill out ratings and have blood drawn to measure hormone levels
Detailed Description:
Results from previous protocols 90-M-0088 and 92-M-0174 have demonstrated that women with menstrually-related mood disorder MRMD but not women lacking this disorder experience mood deterioration within approximately a week after exposure to either estradiol or progesterone in the context of gonadal suppression induced by use of the depot gonadotropin releasing hormone agonist leuprolide acetate It is unknown whether this hormone-induced depression occurs consequent to changes in gonadal steroid levels or to simple exposure to levels above a critical threshold Additionally since the symptoms of depression stimulated by hormone addback appeared to remit by the fourth week of hormone administration it is unclear whether continued administration of hormone would result in continued or repeated experience of depression or whether no further symptoms would appear subsequent to the initial precipitated episode To address these points of uncertainty we first will establish the efficacy of gonadal suppression in our MRMD subjects by administering depot leuprolide acetate for three months and then will administer both estradiol and progesterone in a continuous fashion for three months to determine whether maintenance of stable gonadal steroid levels will prevent the characteristic cyclic mood disorder
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 |
|---|---|---|---|
| 00-M-0103 | None | None | None |