Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332033
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-05-31
Brief Title:
Development of a Non-Invasive Treatment for Uterine Leiomyoma Fibroids
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:
Development of a Non-Invasive Treatment for Uterine Leiomyoma Fibroids
Status:
COMPLETED
Status Verified Date:
2007-02-16
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 leiomyomas fibroids represent a major public health problem with few effective therapies Currently the only definitive treatment is hysterectomy and women are demanding alternative therapies to surgery We have developed a new approach to the treatment of uterine fibroids based on collaborative laboratory research into the molecular ultra-structural and histopathologic changes that occur with the transformation of normal uterine myocytes into abnormal myocytes comprising uterine fibroids We have confirmed that excessive dysregulated collagen production fibrosis and abnormal collagen deposition is an underlying etiology in the pathogenesis of leiomyoma We will test the hypothesis that an anti-tumor drug Pirfenidone will decrease the size of clinically relevant leiomyomas by 30 The specific aim is to compare the effects of pirfenidone with placebo on uterine leiomyoma volume Thirty-two 32 women will be randomized in a double-blinded treatment design Inclusion criteria include women that have completed child-bearing who are candidates for hysterectomy are using effective contraceptive and have at least one uterine leiomyoma greater than 4 cm diameter confirmed by ultrasound Women will be excluded if they have a body mass index greater than 33 kgm2 other gynecological diseases and history of cardiovascular disease or smoking Response in each treatment group will be assessed by T-2 weighted magnetic resonance imaging MRI and 3-D ultrasound imaging studies during the enrollment period To our knowledge this will be the first study to document the response of large fibroids to a short-term trial of an anti-tumor drug The data will be used to further define the role of fibrosis in leiomyoma and establish other clinical trials to thoroughly evaluate such therapeutic approaches for uterine leiomyomas
Detailed Description:
Uterine leiomyomas fibroids represent a major public health problem with few effective therapies Currently the only definitive treatment is hysterectomy and women are demanding alternative therapies to surgery We have developed a new approach to the treatment of uterine fibroids based on collaborative laboratory research into the molecular ultra-structural and histopathologic changes that occur with the transformation of normal uterine myocytes into abnormal myocytes comprising uterine fibroids We have confirmed that excessive dysregulated collagen production fibrosis and abnormal collagen deposition is an underlying etiology in the pathogenesis of leiomyoma We will test the hypothesis that an anti-tumor drug Pirfenidone will decrease the size of clinically relevant leiomyomas by 30 The specific aim is to compare the effects of pirfenidone with placebo on uterine leiomyoma volume Thirty-two 32 women will be randomized in a double-blinded treatment design Inclusion criteria include women that have completed child-bearing who are candidates for hysterectomy are using effective contraceptive and have at least one uterine leiomyoma greater than 4 cm diameter confirmed by ultrasound Women will be excluded if they have a body mass index greater than 33 kgm2 other gynecological diseases and history of cardiovascular disease or smoking Response in each treatment group will be assessed by T-2 weighted magnetic resonance imaging MRI and 3-D ultrasound imaging studies during the enrollment period To our knowledge this will be the first study to document the response of large fibroids to a short-term trial of an anti-tumor drug The data will be used to further define the role of fibrosis in leiomyoma and establish other clinical trials to thoroughly evaluate such therapeutic approaches for uterine leiomyomas
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 |
|---|---|---|---|
| 06-CH-0029 | None | None | None |