A Phase 2 interventional study of Cabergoline and Norethindrone acetate in Endometriosis, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to female participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Boston Children's Hospital · Phase 2, Interventional, and Treatment
The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent, cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of endometriosis-associated pain in young women with endometriosis.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 10 is below the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria:
Norethindrone acetate 5 mg po daily x 6 months
Drug: Norethindrone acetate
cabergoline 0.5 mg PO twice weekly x 6 months
Drug: Cabergoline
Also known as: Dostinex
Also known as: Aygestin
Change in Score in Worst Pain Over the Last Month
visual analog scale, minimum=0 and maximum=10 Higher numbers are a worse outcome Outcome measures is calculated as the value at 6 months minus value at baseline.
Time frame: Baseline, 6 months
Changes in Pain Interference Scores
Brief Pain Inventory Interference subscale is a 7-item self-report measure, designed to assess the extent to which pain interferes with various components of functioning, including physical and emotional functioning and sleep.The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assess the extent to which pain interferes with sleep. The arithmetic mean of the seven interference items is used as a measure of pain interference (i.e., how much a participant's pain interferes with her ability to complete activities of daily living and functioning). The score on the pain interference subscale ranges from 0-70. Higher scores are worse outcomes. Outcome measure calculated as the value at 6 months minus the value at baseline
Time frame: Baseline, 6 months
| Milestone | Norethindrone Acetate 5 mg Daily | Cabergoline 0.5 mg Twice Weekly |
|---|---|---|
| Started | 5 | 5 |
| Completed | 3 | 4 |
| Not completed | 2 | 1 |
visual analog scale, minimum=0 and maximum=10 Higher numbers are a worse outcome Outcome measures is calculated as the value at 6 months minus value at baseline.
| score on a scale | Norethindrone Acetate 5 mg | Cabergoline 0.5 mg |
|---|---|---|
| Change in Score in Worst Pain Over the Last Month | -0.5 ± 1.5 | -5 ± 2.5 |
Brief Pain Inventory Interference subscale is a 7-item self-report measure, designed to assess the extent to which pain interferes with various components of functioning, including physical and emotional functioning and sleep.The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assess the extent to which pain interferes with sleep. The arithmetic mean of the seven interference items is used as a measure of pain interference (i.e., how much a participant's pain interferes with her ability to complete activities of daily living and functioning). The score on the pain interference subscale ranges from 0-70. Higher scores are worse outcomes. Outcome measure calculated as the value at 6 months minus the value at baseline
| units on a scale | Norethindrone Acetate 5 mg | Cabergoline 0.5 mg |
|---|---|---|
| Changes in Pain Interference Scores | 0.85 ± 1.1 | 0 ± 1.1 |
Collected over 6 MONTHS. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Experimental | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Control | Experimental |
|---|---|---|
| NAUSEAGastrointestinal disorders | 1/4 | 5/5 |
| IRREGULAR VAGINAL BLEEDINGReproductive system and breast disorders | 2/4 | 2/5 |
| FATIGUEGeneral disorders | 1/4 | 2/5 |
| Age, Continuous(years) | Control | Experimental | Total |
|---|---|---|---|
| Median | 25.2 ± 8.7 | 24.8 ± 2.8 | 24.8 ± 5.8 |
| Sex: Female, Male(Participants) | Control | Experimental | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Experimental | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 2 | 3 | 5 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Control | Experimental | Total |
|---|---|---|---|
| United States | 4 | 5 | 9 |
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