Trial Outcomes & Findings for Cannabidiol and Management of Endometriosis Pain (NCT NCT04527003)
NCT ID: NCT04527003
Last Updated: 2025-04-04
Results Overview
Pain will be self-reported daily using the Visual Analog Scale, a 100mm horizontal line on which the patient's pain intensity is represented by a point between the extremities of 0 (no pain) and 100 (worst pain). Although the daily collection is based on the 0-100 point scale, the primary study endpoint is calculated as the area under the curve per patient using the trapezoidal rule, with an AUC range per patient of 0-5600 over 8 weeks.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-04-04
Participant Flow
Between screening and randomization, subjects entered a run-in phase collecting daily electronic diaries. Subjects were excluded from randomization if they were not at least 80% adherent with completion of the daily diaries.
Participant milestones
| Measure |
Group A - Placebo
Norethindrone acetate (5mg daily) + Placebo
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
Placebo: a substance or treatment which is designed to have no therapeutic value
|
Group B - Low Dose CBD
Norethindrone acetate (5mg daily) + Low dose CBD (10mg sublingual daily)
Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
|
Group C - High Dose CBD
Norethindrone acetate (5mg daily) + High dose CBD (20mg sublingual daily)
Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
4
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cannabidiol and Management of Endometriosis Pain
Baseline characteristics by cohort
| Measure |
Group A - Placebo
n=4 Participants
Norethindrone acetate (5mg daily) + Placebo
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
Placebo: a substance or treatment which is designed to have no therapeutic value
|
Group B - Low Dose CBD
n=3 Participants
Norethindrone acetate (5mg daily) + Low dose CBD (10mg sublingual daily)
Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
|
Group C - High Dose CBD
n=3 Participants
Norethindrone acetate (5mg daily) + High dose CBD (20mg sublingual daily)
Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
28.9 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Subjects who completed the study
Pain will be self-reported daily using the Visual Analog Scale, a 100mm horizontal line on which the patient's pain intensity is represented by a point between the extremities of 0 (no pain) and 100 (worst pain). Although the daily collection is based on the 0-100 point scale, the primary study endpoint is calculated as the area under the curve per patient using the trapezoidal rule, with an AUC range per patient of 0-5600 over 8 weeks.
Outcome measures
| Measure |
Group A - Placebo
n=4 Participants
Norethindrone acetate (5mg daily) + Placebo
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
Placebo: a substance or treatment which is designed to have no therapeutic value
|
Group B - Low Dose CBD
n=2 Participants
Norethindrone acetate (5mg daily) + Low dose CBD (10mg sublingual daily)
Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
|
Group C - High Dose CBD
n=1 Participants
Norethindrone acetate (5mg daily) + High dose CBD (20mg sublingual daily)
Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
|
|---|---|---|---|
|
Pain Score Area Under the Curve (AUC)
|
2254 score on a scale*days
Interval 1803.0 to 2662.0
|
2211 score on a scale*days
Interval 1455.0 to 2968.0
|
1042 score on a scale*days
Interval 1042.0 to 1042.0
|
Adverse Events
Group A - Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group B - Low Dose CBD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group C - High Dose CBD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A - Placebo
n=4 participants at risk
Norethindrone acetate (5mg daily) + Placebo
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
Placebo: a substance or treatment which is designed to have no therapeutic value
|
Group B - Low Dose CBD
n=3 participants at risk
Norethindrone acetate (5mg daily) + Low dose CBD (10mg sublingual daily)
Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
|
Group C - High Dose CBD
n=3 participants at risk
Norethindrone acetate (5mg daily) + High dose CBD (20mg sublingual daily)
Cannabidiol (CBD) Extract: Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
Norethindrone Acetate: Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
33.3%
1/3 • Number of events 1 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
|
Gastrointestinal disorders
Stomach pain
|
25.0%
1/4 • Number of events 1 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
|
Nervous system disorders
Headaches
|
0.00%
0/4 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
33.3%
1/3 • Number of events 1 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
|
General disorders
Gagging (when taking study drug)
|
0.00%
0/4 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
33.3%
1/3 • Number of events 1 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
|
Reproductive system and breast disorders
Night sweats
|
25.0%
1/4 • Number of events 1 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
|
Renal and urinary disorders
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
|
General disorders
ulcer on lip
|
25.0%
1/4 • Number of events 1 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
0.00%
0/3 • 12 weeks
At follow-up visits (4 weeks, 8 weeks, 12 weeks), adverse event assessment will include, but is not limited to: 1. Detailed, directed review of systems 2. Vital signs 3. Examination of oral cavity (to assess for lesions/sores) 4. Physical exam
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place