Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290251
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2006-02-10
Brief Title:
Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata
Status:
COMPLETED
Status Verified Date:
2024-07
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 will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women
Detailed Description:
Uterine leiomyomata fibroids are a common benign tumor of the uterine muscle in pre-menopausal women that may cause bleeding pelvic pain and pressure Because fibroids grow in the presence of estrogen medical therapies that decrease estrogen levels like Gonadotropin releasing hormoneGnRH 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-flashes Thus many women with symptomatic fibroids choose to have them removed surgically either individually or by removing the uterus via hysterectomy
Women between 25 and 50 years of age who have regular menstrual cycles and a history of uterine fibroids that cause heavy bleeding pressure or pain may be eligible for this study Candidates are screened with a medical history and physical examination including breast and pelvic examination blood and urine tests a quality-of-life questionnaire and a home urine test for leuteinizing hormone LH surge They are given a diary to record the LH surge days of vaginal spotting or bleeding and symptoms Participation includes the following
Baseline Studies First Menstrual Cycle
Magnetic resonance imaging MRI The subject lies in the MRI scanner a narrow cylinder with a strong magnetic field for imaging the uterus
Saline hysterosonogram This is an ultrasound examination of the uterus A speculum is placed in the vagina and a small amount of liquid is inserted into the uterus A probe is then inserted into the vagina The probe emits and receives sound waves that are used to visualize the fibroids and surrounding structures
Study Drug Phase Second through Fourth Menstrual Cycles
Subjects are randomly assigned to take ulipristal acetate or placebo inactive compound once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop
Pregnancy test on first or second day of every menstrual cycle
Blood tests every 2 weeks to measure effects of study medication on hormones blood count blood chemistries and liver function
24-hour urine collections three times during the study about once a month to measure cortisol and check adrenal gland function
Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth
Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids or placebo inactive compound once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop
Pregnancy test on first or second day of every menstrual cycle
Blood tests every 2 weeks to measure effects of study medication on hormones blood count blood chemistries and liver function
24-hour urine collections three times during the study about once a month to measure cortisol and check adrenal gland function
Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth
Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids or placebo inactive compound once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop
Pregnancy test on first or second day of every menstrual cycle
Blood tests every 2 weeks to measure effects of study medication on hormones blood count blood chemistries and liver function
24-hour urine collections three times during the study about once a month to measure cortisol and check adrenal gland function
Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth
Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids
Women between 25 and 50 years of age who have regular menstrual cycles and a history of uterine fibroids that cause heavy bleeding pressure or pain may be eligible for this study Candidates are screened with a medical history and physical examination including breast and pelvic examination blood and urine tests a quality-of-life questionnaire and a home urine test for leuteinizing hormone LH surge They are given a diary to record the LH surge days of vaginal spotting or bleeding and symptoms Participation includes the following
Baseline Studies First Menstrual Cycle
Magnetic resonance imaging MRI The subject lies in the MRI scanner a narrow cylinder with a strong magnetic field for imaging the uterus
Saline hysterosonogram This is an ultrasound examination of the uterus A speculum is placed in the vagina and a small amount of liquid is inserted into the uterus A probe is then inserted into the vagina The probe emits and receives sound waves that are used to visualize the fibroids and surrounding structures
Study Drug Phase Second through Fourth Menstrual Cycles
Subjects are randomly assigned to take ulipristal acetate or placebo inactive compound once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop
Pregnancy test on first or second day of every menstrual cycle
Blood tests every 2 weeks to measure effects of study medication on hormones blood count blood chemistries and liver function
24-hour urine collections three times during the study about once a month to measure cortisol and check adrenal gland function
Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth
Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids or placebo inactive compound once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop
Pregnancy test on first or second day of every menstrual cycle
Blood tests every 2 weeks to measure effects of study medication on hormones blood count blood chemistries and liver function
24-hour urine collections three times during the study about once a month to measure cortisol and check adrenal gland function
Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth
Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids or placebo inactive compound once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop
Pregnancy test on first or second day of every menstrual cycle
Blood tests every 2 weeks to measure effects of study medication on hormones blood count blood chemistries and liver function
24-hour urine collections three times during the study about once a month to measure cortisol and check adrenal gland function
Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth
Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids
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-0090 | OTHER | NIH IRB | httpsreporternihgovquickSearch1ZIAHD000637-17 |
| 1ZIAHD000637-17 | NIH | None | None |