Trial Outcomes & Findings for Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study (NCT NCT02542410)

Last Updated: 2020-02-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2020-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Norethindrone Acetate 5 mg Daily Norethindrone acetate 5 mg po daily x 6 months Norethindrone acetate	Cabergoline 0.5 mg Twice Weekly cabergoline 0.5 mg PO twice weekly x 6 months Cabergoline
Overall Study STARTED	5	5
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=4 Participants Norethindrone acetate 5 mg po daily x 6 months Norethindrone acetate	Experimental n=5 Participants cabergoline 0.5 mg PO twice weekly x 6 months Cabergoline	Total n=9 Participants Total of all reporting groups
Age, Continuous	25.2 years STANDARD_DEVIATION 8.7 • n=5 Participants	24.8 years STANDARD_DEVIATION 2.8 • n=7 Participants	24.8 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

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.

Outcome measures

Outcome measures
Measure	Norethindrone Acetate 5 mg n=4 Participants Norethindrone acetate 5 mg po daily x 6 months Norethindrone acetate	Cabergoline 0.5 mg n=5 Participants cabergoline 0.5 mg PO twice weekly x 6 months Cabergoline
Change in Score in Worst Pain Over the Last Month	-0.5 score on a scale Standard Deviation 1.5	-5 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline, 6 months

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

Outcome measures

Outcome measures
Measure	Norethindrone Acetate 5 mg n=4 Participants Norethindrone acetate 5 mg po daily x 6 months Norethindrone acetate	Cabergoline 0.5 mg n=5 Participants cabergoline 0.5 mg PO twice weekly x 6 months Cabergoline
Changes in Pain Interference Scores	0.85 units on a scale Standard Error 1.1	0 units on a scale Standard Error 1.1

Adverse Events

Control

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=4 participants at risk Norethindrone acetate 5 mg po daily x 6 months Norethindrone acetate	Experimental n=5 participants at risk cabergoline 0.5 mg PO twice weekly x 6 months Cabergoline
Reproductive system and breast disorders IRREGULAR VAGINAL BLEEDING	50.0% 2/4 • Number of events 2 • 6 MONTHS	40.0% 2/5 • Number of events 3 • 6 MONTHS
Gastrointestinal disorders NAUSEA	25.0% 1/4 • Number of events 1 • 6 MONTHS	100.0% 5/5 • Number of events 5 • 6 MONTHS
General disorders FATIGUE	25.0% 1/4 • Number of events 1 • 6 MONTHS	40.0% 2/5 • Number of events 5 • 6 MONTHS

Additional Information

DR. AMY DIVASTA

BOSTON CHILDREN'S HOSPITAL

Phone: 6173556000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place