Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044876
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2002-09-05
Brief Title:
Treatment of Uterine Fibroids With CDB-2914 an Experimental Selective Progesterone Receptor Antagonist
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Leiomyomata With the Selective Progesterone Receptor Modulator CDB-2914
Status:
COMPLETED
Status Verified Date:
2015-10-01
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:
Uterine leiomyomata fibroids are a common benign tumor of the uterine muscle in premenopausal women These tumors may cause bleeding pelvic pain and pressure Because fibroids grow in the presence of estrogen medical therapies that decrease estrogen levels like GnRH analog cause fibroids to shrink and so may relieve symptoms However such medication can only be given short-term and has inconvenient side effects such as hot-flushes Thus many women with symptomatic fibroids choose to have them removed surgically either individually or by removing the uterus via hysterectomy
The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914 A similar compound mifepristone Registered Trademark reduced fibroid size when given for twelve weeks This study will compare fibroid size hormone levels and symptoms before and during daily administration of CDB-2914 10 or 25 mg or placebo for 10 - 14 weeks To do this women will undergo MRI and a saline hysterosonogram ultrasound with fluid of the uterus before and at the end of the treatment they will have blood drawn every 7 - 14 days and will fill out a symptom calendar at home Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues and to provide treatment for the study participant Women will be randomly assigned to the treatment groups during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives
The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914 A similar compound mifepristone Registered Trademark reduced fibroid size when given for twelve weeks This study will compare fibroid size hormone levels and symptoms before and during daily administration of CDB-2914 10 or 25 mg or placebo for 10 - 14 weeks To do this women will undergo MRI and a saline hysterosonogram ultrasound with fluid of the uterus before and at the end of the treatment they will have blood drawn every 7 - 14 days and will fill out a symptom calendar at home Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues and to provide treatment for the study participant Women will be randomly assigned to the treatment groups during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives
Detailed Description:
Uterine leiomyomata fibroids are a common benign tumor of the uterine muscle in premenopausal women These tumors may cause bleeding pelvic pain and pressure Because fibroids grow in the presence of estrogen medical therapies that decrease estrogen levels like GnRH analog cause fibroids to shrink and so may relieve symptoms However such medication can only be given short-term and has inconvenient side effects such as hot-flushes Thus many women with symptomatic fibroids choose to have them removed surgically either individually or by removing the uterus via hysterectomy
The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914 A similar compound mifepristone Registered Trademark reduced fibroid size when given for twelve weeks This study will compare fibroid size hormone levels and symptoms before and during daily administration of CDB-2914 10 or 25 mg or placebo for 10 - 14 weeks To do this women will undergo MRI and a saline hysterosonogram ultrasound with fluid of the uterus before and at the end of the treatment they will have blood drawn every 7 - 14 days and will fill out a symptom calendar at home Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues and to provide treatment for the study participant Women will be randomly assigned to the treatment groups during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives
The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914 A similar compound mifepristone Registered Trademark reduced fibroid size when given for twelve weeks This study will compare fibroid size hormone levels and symptoms before and during daily administration of CDB-2914 10 or 25 mg or placebo for 10 - 14 weeks To do this women will undergo MRI and a saline hysterosonogram ultrasound with fluid of the uterus before and at the end of the treatment they will have blood drawn every 7 - 14 days and will fill out a symptom calendar at home Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues and to provide treatment for the study participant Women will be randomly assigned to the treatment groups during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives
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 |
|---|---|---|---|
| 02-CH-0287 | None | None | None |