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The aim of this research is to assess the benefit of a medication (ulipristal) for alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.
This study will assess the use of a medication to improve symptoms of chronic, endometriosis-related pelvic pain among women who did no achieve relief with prior surgical and medical treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulipristal | Experimental | 1 patient with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal | Drug | Patient will take 15mg every other day, or every 4 days per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Pain | Scores were collected daily and averaged together for each period | Patients will document self-reported daily pain scores via visual analogue scale(0 to10 where 0 is no pain and 10 is worst pain)for one month prior to starting treatment (1 month),while receiving treatment (3 months) after cessation of treatment (1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Bleeding | Patient will record the # of tampons or pads they use each week while enrolled in the study (1 month pre-medication, 3 months during medication, 1 month after medication). | 5 months |
| Pain With Sexual Intercourse |
| Measure | Description | Time Frame |
|---|---|---|
| Pain With Bowel Movements | Patient will document self-reported weekly average pelvic pain scores with defecation (0 to 10 where 0 is no pain and 10 is worst pain) for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment. | Patient will document self-reported daily pain scores via visual analogue scale(0 to 10 where 0 is no pain and 10 is worst pain) for one month prior to starting treatment (1 month),while receiving treatment (3 months)after cessation of treatment(1 month) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serdar Bulun | Northwestern University, Northwestern Memorial Hopsital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University, Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ulipristal | 1 patient with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies received 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ulipristal | 1 patient with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months. Ulipristal: Patient will take 15mg every other day, or every 4 days per week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pelvic Pain | Scores were collected daily and averaged together for each period | Posted | Mean | Standard Error | units on a scale | Patients will document self-reported daily pain scores via visual analogue scale(0 to10 where 0 is no pain and 10 is worst pain)for one month prior to starting treatment (1 month),while receiving treatment (3 months) after cessation of treatment (1 month) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ulipristal | 1 patient with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months. Ulipristal: Patient will take 15mg every other day, or every 4 days per week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Serdar Bulun | Northwestern University | 312-472-3980 | Serdar.Bulun@nm.org |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| D003248 | Constipation |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C094854 | ulipristal |
| C555622 | ulipristal acetate |
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If sexually active, patients will document self-reported weekly average pelvic pain scores (0 to 10 where 0 is no pain and 10 is worst pain) with sexual intercourse for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.
| 5 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Vaginal Bleeding | Patient will record the # of tampons or pads they use each week while enrolled in the study (1 month pre-medication, 3 months during medication, 1 month after medication). | Posted | Number | pads or tampons | 5 months |
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| Secondary | Pain With Sexual Intercourse | If sexually active, patients will document self-reported weekly average pelvic pain scores (0 to 10 where 0 is no pain and 10 is worst pain) with sexual intercourse for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment. | The one patient in our study was not sexually active during her enrollment in the study such that dyspareunia pain scores were unable to be assessed. | Posted | 5 months |
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| Other Pre-specified | Pain With Bowel Movements | Patient will document self-reported weekly average pelvic pain scores with defecation (0 to 10 where 0 is no pain and 10 is worst pain) for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment. | Our one patient did not report dyschezia before, during, or after ulipristal treatment. | Posted | Number | units on a scale | Patient will document self-reported daily pain scores via visual analogue scale(0 to 10 where 0 is no pain and 10 is worst pain) for one month prior to starting treatment (1 month),while receiving treatment (3 months)after cessation of treatment(1 month) |
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| 0 |
| 1 |
| 0 |
| 1 |
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| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| Measurements |
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| Title | Measurements |
|---|---|
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