Trial Outcomes & Findings for Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction (NCT NCT00181961)
NCT ID: NCT00181961
Last Updated: 2019-08-21
Results Overview
Full title: Massachusetts General Hospital Sexual Dysfunction Inventory Minimum score for Men: 5 Minimum score for Women: 4 Maximum score for Men: 30 Maximum score for Women: 24 \*One item on the measure is for men only A score of a 5 (4 for women) indicates improvement in sexual function. A score of 10 (8 for women) indicates no change. A score higher than 10 (8 for women) indicates a level of sexual dysfunction.
COMPLETED
PHASE3
20 participants
baseline to endpoint (8 weeks)
2019-08-21
Participant Flow
Participant milestones
| Measure |
Maca Root 1500mg
Patients receiving 1500mg of maca root
Maca Root
|
Maca Root 3000mg
Patients receiving 3000mg of maca root
Maca Root
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction
Baseline characteristics by cohort
| Measure |
Maca Root 1500mg
n=7 Participants
Patients receiving 1500mg of maca root
Maca Root
|
Maca Root 3000mg
n=9 Participants
Patients receiving 3000mg of maca root
Maca Root
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 12 • n=5 Participants
|
34 years
STANDARD_DEVIATION 15 • n=7 Participants
|
36 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 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
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to endpoint (8 weeks)Full title: Massachusetts General Hospital Sexual Dysfunction Inventory Minimum score for Men: 5 Minimum score for Women: 4 Maximum score for Men: 30 Maximum score for Women: 24 \*One item on the measure is for men only A score of a 5 (4 for women) indicates improvement in sexual function. A score of 10 (8 for women) indicates no change. A score higher than 10 (8 for women) indicates a level of sexual dysfunction.
Outcome measures
| Measure |
Maca Root 1500mg
n=7 Participants
Patients receiving 1500mg of maca root
Maca Root
|
Maca Root 3000mg
n=9 Participants
Patients receiving 3000mg of maca root
Maca Root
|
|---|---|---|
|
Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores
|
.249 score on a scale
Standard Deviation 2.39
|
.017 score on a scale
Standard Deviation 1.15
|
Adverse Events
Maca Root 1500mg
Maca Root 3000mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maca Root 1500mg
n=7 participants at risk
Patients receiving 1500mg of maca root
Maca Root
|
Maca Root 3000mg
n=9 participants at risk
Patients receiving 3000mg of maca root
Maca Root
|
|---|---|---|
|
Gastrointestinal disorders
GI Upset
|
28.6%
2/7 • Number of events 6
|
33.3%
3/9 • Number of events 4
|
|
General disorders
Headache
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Irritability
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Urinary Frequency
|
0.00%
0/7
|
11.1%
1/9 • Number of events 2
|
|
General disorders
Sleep issues
|
14.3%
1/7 • Number of events 3
|
0.00%
0/9
|
|
General disorders
Thicker Menstrual Discharge
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Fibromyalgia Exacerbation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place