Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089414
Status:
TERMINATED
Last Update Posted:
2017-08-25
First Post:
2004-08-04
Brief Title:
Treatment of Menstrually Related Disorders With Continuous v Interrupted Oral Contraceptives
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 Extended Versus Interrupted Oral Contraceptives
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Informed by manufacturer that CDB-2914 crosses blood-brain barrier invalidating Arm 3 of protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether uninterrupted treatment with birth control pills over several menstrual cycles prevents severe premenstrual syndrome PMDD
Previous studies have shown that the hormones estrogen and progesterone regulate mood in women with MRMD This study will use various treatment regimens with birth control pills and placebo sugar pill to clarify the relationships among estrogen and progesterone the menstrual cycle and mood
Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week study Candidates are screened with a physical examination blood and urine tests an electrocardiogram and 3 months of symptoms ratings to confirm MRMD
Participants are randomly assigned to one of three treatment groups Group 1 takes a birth control pill every day and on three occasions takes a placebo capsule Group 2 takes a birth control pill most but not all days and on three occasions takes a placebo capsule Group 3 takes a birth control pill every day and on three occasions takes another medication called CDB-2914 that causes menstrual bleeding to occur
Participants come to the NIH clinic every other week for blood tests and measurement of vital signs blood pressure pulse and temperature and to complete symptoms ratings scales Subjects who develop breakthrough bleeding menstruation earlier than expected will have a transvaginal ultrasound For this procedure a probe is inserted into the vagina for about 10 minutes The probe gives off and receives sound waves that can be used to form a picture of the endometrium lining of the uterus
Previous studies have shown that the hormones estrogen and progesterone regulate mood in women with MRMD This study will use various treatment regimens with birth control pills and placebo sugar pill to clarify the relationships among estrogen and progesterone the menstrual cycle and mood
Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week study Candidates are screened with a physical examination blood and urine tests an electrocardiogram and 3 months of symptoms ratings to confirm MRMD
Participants are randomly assigned to one of three treatment groups Group 1 takes a birth control pill every day and on three occasions takes a placebo capsule Group 2 takes a birth control pill most but not all days and on three occasions takes a placebo capsule Group 3 takes a birth control pill every day and on three occasions takes another medication called CDB-2914 that causes menstrual bleeding to occur
Participants come to the NIH clinic every other week for blood tests and measurement of vital signs blood pressure pulse and temperature and to complete symptoms ratings scales Subjects who develop breakthrough bleeding menstruation earlier than expected will have a transvaginal ultrasound For this procedure a probe is inserted into the vagina for about 10 minutes The probe gives off and receives sound waves that can be used to form a picture of the endometrium lining of the uterus
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 one to two weeks 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 Preliminary results of protocol 00-M-0103 suggest that this hormone-induced depression occurs consequent to changes in gonadal steroid levels and not to simple exposure to basal levels above a critical threshold Additionally continued administration of hormone for three months resulted in no further symptoms subsequent to the initial precipitated episode These data suggest the potential therapeutic benefit of extended oral contraceptive OC regimens with reduced pill-free intervals in MRMD to minimize the mood destabilizing effects of changing hormone levels In this protocol we examine whether the effects of 15 weeks of continuous oral contraceptive administration causes a remission of symptoms in women with MRMD
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 |
|---|---|---|---|
| 04-M-0221 | None | None | None |