Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00290251
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2006-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
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:
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 hormone,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-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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1ZIAHD000637-17 | NIH | None | https://reporter.nih.gov/quic… | View |
| 06-CH-0090 | OTHER | NIH IRB | View |