Trial Outcomes & Findings for Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache (NCT NCT00963040)
NCT ID: NCT00963040
Last Updated: 2023-06-15
Results Overview
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
2 hours after administration of study medication
Results posted on
2023-06-15
Participant Flow
Subjects recruited at dedicated research center
In total 79 subjects were screened, of which five were screen failures in the strict sense of the word and 14 were not randomized because the 6-week treatment period had elapsed.
Participant milestones
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
Self-administered by participants in the upright sitting position with the neck flexed. The pump was primed and one nostril was closed with the finger. The tip of the bottle was inserted into the other nostril at an angle of 60 degrees. One actuation (4 IU) was administered while gently sniffing through that nostril. The tip of the bottle was then inserted into the other nostril for administration of another 4 IU. This procedure was repeated three times with 5-minute intervals (allowing for medication uptake and clearance) for a total dose of 32 IU followed by in-clinic observation for 2 hours post-dose in the TI004 study
|
Placebo TI-004 Protocol
Administration of placebo similar to oxytocin arm: 4 actuations in each nostril of sterile water with in-clinic observation for 2 hours post-dose in the TI004 study
|
Syntocinon® (Oxytocin) TI-005 Protocol
Self-administered by participants in the upright sitting position with the neck flexed. The pump was primed and one nostril was closed with the finger. The tip of the bottle was inserted into the other nostril at an angle of 60 degrees. One actuation (4 IU) was administered while gently sniffing through that nostril. The tip of the bottle was then inserted into the other nostril for administration of another 4 IU. This procedure was repeated seven times with 5-minute intervals (allowing for medication uptake and clearance) for a total dose of 64 IU followed by 4 hours post-dose in-clinic observation in the TI005 study.
|
Placebo TI-005 Protocol
Administration of placebo similar to oxytocin arm: 7 actuations of sterile with 5-minute intervals followed by 4 hours post-dose of in-clinic observation in the TI005 study.
|
|---|---|---|---|---|
|
TI-004 Protocol
STARTED
|
22
|
18
|
0
|
0
|
|
TI-004 Protocol
COMPLETED
|
22
|
18
|
0
|
0
|
|
TI-004 Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
TI-005 Protocol
STARTED
|
0
|
0
|
12
|
8
|
|
TI-005 Protocol
COMPLETED
|
0
|
0
|
12
|
8
|
|
TI-005 Protocol
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
Baseline characteristics by cohort
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
n=22 Participants
32 IU intranasally
|
Placebo TI-004 Protocol
n=18 Participants
Sterile water intranasally
|
Syntocinon® (Oxytocin) TI-005 Protocol
n=12 Participants
64 IU intranasally
|
Placebo TI-005 Protocol
n=8 Participants
Sterile water intranasally
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Protocol TI-004
|
44.5 years
STANDARD_DEVIATION 11.37 • n=39 Participants
|
41.0 years
STANDARD_DEVIATION 9.4 • n=41 Participants
|
NA years
STANDARD_DEVIATION NA • n=35 Participants
|
NA years
STANDARD_DEVIATION NA • n=31 Participants
|
42.9 years
STANDARD_DEVIATION 10.6 • n=146 Participants
|
|
Age, Continuous
Protocol TI-005
|
NA years
STANDARD_DEVIATION NA • n=39 Participants
|
NA years
STANDARD_DEVIATION NA • n=41 Participants
|
45.0 years
STANDARD_DEVIATION 10.8 • n=35 Participants
|
39.5 years
STANDARD_DEVIATION 15.1 • n=31 Participants
|
42.8 years
STANDARD_DEVIATION 12.6 • n=146 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
36 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
24 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
57 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
13 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
22 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
20 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 2 hours after administration of study medicationNumber (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Outcome measures
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
n=22 Participants
32 IU intranasally
|
Placebo TI-004 Protocol
n=18 Participants
Sterile water intranasally
|
Syntocinon® (Oxytocin) TI-005 Protocol
n=12 Participants
64 IU intranasally
|
Placebo TI-005 Protocol
n=8 Participants
Sterile water intranasally
|
|---|---|---|---|---|
|
Reduction in Headache Intensity
|
6 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medicationPopulation: Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Outcome measures
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
n=22 Participants
32 IU intranasally
|
Placebo TI-004 Protocol
n=18 Participants
Sterile water intranasally
|
Syntocinon® (Oxytocin) TI-005 Protocol
n=12 Participants
64 IU intranasally
|
Placebo TI-005 Protocol
n=8 Participants
Sterile water intranasally
|
|---|---|---|---|---|
|
Reduction in Headache Intensity
0.5 hours after administration
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Reduction in Headache Intensity
1 hour after administration
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Reduction in Headache Intensity
3 hours after administration
|
—
|
—
|
1 Participants
|
4 Participants
|
|
Reduction in Headache Intensity
4 hours after administration
|
11 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Reduction in Headache Intensity
8 hours after administration
|
—
|
—
|
4 Participants
|
5 Participants
|
|
Reduction in Headache Intensity
24 hours after administration
|
10 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medicationPopulation: Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol
Average headache intensity as rated on the 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
Outcome measures
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
n=22 Participants
32 IU intranasally
|
Placebo TI-004 Protocol
n=18 Participants
Sterile water intranasally
|
Syntocinon® (Oxytocin) TI-005 Protocol
n=12 Participants
64 IU intranasally
|
Placebo TI-005 Protocol
n=8 Participants
Sterile water intranasally
|
|---|---|---|---|---|
|
Average Headache Intensity
0.5 hours after administration
|
7.1 score on a scale
Standard Deviation 1.5
|
7.1 score on a scale
Standard Deviation 1.6
|
6.5 score on a scale
Standard Deviation 0.8
|
6.1 score on a scale
Standard Deviation 1.2
|
|
Average Headache Intensity
1 hour after administration
|
6.2 score on a scale
Standard Deviation 2.3
|
6.5 score on a scale
Standard Deviation 1.3
|
6.1 score on a scale
Standard Deviation 1.1
|
5.7 score on a scale
Standard Deviation 1.8
|
|
Average Headache Intensity
2 hours after administration
|
5.8 score on a scale
Standard Deviation 2.2
|
5.9 score on a scale
Standard Deviation 1.7
|
5.7 score on a scale
Standard Deviation 1.1
|
4.6 score on a scale
Standard Deviation 1.9
|
|
Average Headache Intensity
3 hours after administration
|
—
|
—
|
4.8 score on a scale
Standard Deviation 1.7
|
3.5 score on a scale
Standard Deviation 2.1
|
|
Average Headache Intensity
4 hours after administration
|
3.8 score on a scale
Standard Deviation 2.9
|
6.0 score on a scale
Standard Deviation 1.9
|
3.9 score on a scale
Standard Deviation 2.6
|
2.8 score on a scale
Standard Deviation 2.2
|
|
Average Headache Intensity
8 hours after administration
|
—
|
—
|
4.3 score on a scale
Standard Deviation 2.5
|
3.0 score on a scale
Standard Deviation 2.3
|
|
Average Headache Intensity
24 hours after administration
|
4.2 score on a scale
Standard Deviation 2.8
|
4.5 score on a scale
Standard Deviation 3.0
|
3.5 score on a scale
Standard Deviation 3.0
|
1.8 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medicationPopulation: Number of participants analyzed indicates the number of participants available at each time point. 3 hours and 8 hours were not collected for TI-004 protocol
Number (percentage) of participants with effects of oxytocin on symptoms associated with chronic daily headache, such as nausea, vomiting, photophobia, and phonophobia
Outcome measures
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
n=22 Participants
32 IU intranasally
|
Placebo TI-004 Protocol
n=18 Participants
Sterile water intranasally
|
Syntocinon® (Oxytocin) TI-005 Protocol
n=12 Participants
64 IU intranasally
|
Placebo TI-005 Protocol
n=8 Participants
Sterile water intranasally
|
|---|---|---|---|---|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Phonophobia at 2 hours
|
10 Participants
|
9 Participants
|
3 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Phonophobia at 3 hours
|
—
|
—
|
3 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Phonophobia at 4 hours
|
6 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Phonophobia at 8 hours
|
—
|
—
|
2 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Phonophobia at 24 hours
|
4 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Nausea at 0.5 hours
|
7 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Nausea at 1 hour
|
5 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Nausea at 2 hours
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Nausea at 3 hours
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Nausea at 4 hours
|
2 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Nausea at 8 hours
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Nausea at 24 hours
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Vomiting at 0.5 hours
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Vomiting at 1 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Vomiting at 2 hours
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Vomiting at 3 hours
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Vomiting at 4 hours
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Vomiting at 8 hours
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Vomiting at 24 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Photophobia at 0.5 hours
|
17 Participants
|
15 Participants
|
6 Participants
|
3 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Photophobia at 1 hour
|
14 Participants
|
13 Participants
|
4 Participants
|
2 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Photophobia at 2 hours
|
10 Participants
|
13 Participants
|
4 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Photophobia at 3 hours
|
—
|
—
|
5 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Photophobia at 4 hours
|
7 Participants
|
14 Participants
|
4 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Photophobia at 8 hours
|
—
|
—
|
3 Participants
|
1 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Photophobia at 24 hours
|
9 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Phonophobia at 0.5 hours
|
11 Participants
|
10 Participants
|
6 Participants
|
2 Participants
|
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Phonophobia at 1 hour
|
10 Participants
|
12 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours after intervention administrationPopulation: All randomized participants
Number of participants who took rescue medication (examples: ibuprofen, Tylenol, zolmitriptan) for headache at any time within the 24 hours after intervention administration.
Outcome measures
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
n=22 Participants
32 IU intranasally
|
Placebo TI-004 Protocol
n=18 Participants
Sterile water intranasally
|
Syntocinon® (Oxytocin) TI-005 Protocol
n=12 Participants
64 IU intranasally
|
Placebo TI-005 Protocol
n=8 Participants
Sterile water intranasally
|
|---|---|---|---|---|
|
Intake of Rescue Medication
|
12 Participants
|
10 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours after intervention administrationParticipants rated their satisfaction with treatment on a 4-point scale as "Excellent", "Good", "Moderate", or "Poor". Number (percentage) of participants who reported each rating.
Outcome measures
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
n=22 Participants
32 IU intranasally
|
Placebo TI-004 Protocol
n=18 Participants
Sterile water intranasally
|
Syntocinon® (Oxytocin) TI-005 Protocol
n=12 Participants
64 IU intranasally
|
Placebo TI-005 Protocol
n=8 Participants
Sterile water intranasally
|
|---|---|---|---|---|
|
Participant Satisfaction
"Excellent" satisfaction rating
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Participant Satisfaction
"Good" satisfaction rating
|
7 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Participant Satisfaction
"Moderate" satisfaction rating
|
6 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Participant Satisfaction
"Poor" satisfaction rating
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Participant Satisfaction
Satisfaction rating not reported
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Syntocinon® (Oxytocin) TI-004 Protocol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sterile Water TI-004 Protocol
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Syntocinon® (Oxytocin) TI-005 Protocol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sterile Water TI-005 Protocol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Syntocinon® (Oxytocin) TI-004 Protocol
n=22 participants at risk
Self-administered by participants in the upright sitting position with the neck flexed. The pump was primed and one nostril was closed with the finger. The tip of the bottle was inserted into the other nostril at an angle of 60 degrees. One actuation (4 IU) was administered while gently sniffing through that nostril. The tip of the bottle was then inserted into the other nostril for administration of another 4 IU. This procedure was repeated three times with 5-minute intervals (allowing for medication uptake and clearance) for a total dose of 32 IU followed by in-clinic observation for 2 hours post-dose in the TI004 study.
|
Sterile Water TI-004 Protocol
n=18 participants at risk
Administration of placebo similar to oxytocin arm: 4 actuations in each nostril of sterile water with in-clinic observation for 2 hours post-dose in the TI004 study
|
Syntocinon® (Oxytocin) TI-005 Protocol
n=12 participants at risk
Self-administered by participants in the upright sitting position with the neck flexed. The pump was primed and one nostril was closed with the finger. The tip of the bottle was inserted into the other nostril at an angle of 60 degrees. One actuation (4 IU) was administered while gently sniffing through that nostril. The tip of the bottle was then inserted into the other nostril for administration of another 4 IU. This procedure was repeated seven times with 5-minute intervals (allowing for medication uptake and clearance) for a total dose of 64 IU followed by 4 hours post-dose in-clinic observation in the TI005 study.
|
Sterile Water TI-005 Protocol
n=8 participants at risk
Administration of placebo similar to oxytocin arm: 7 actuations of sterile with 5-minute intervals followed by 4 hours post-dose of in-clinic observation in the TI005 study.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
4.5%
1/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
2/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
5.6%
1/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Infections and infestations
Rhinitis
|
9.1%
2/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Infections and infestations
Sinusitis
|
4.5%
1/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cyst
|
4.5%
1/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Nervous system disorders
Agitation
|
4.5%
1/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.5%
1/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
4.5%
1/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
8.3%
1/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
8.3%
1/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
8.3%
1/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Nervous system disorders
Light headedness
|
0.00%
0/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
5.6%
1/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
0.00%
0/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
5.6%
1/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal irritation
|
0.00%
0/22 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/18 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
0.00%
0/12 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
12.5%
1/8 • Safety was monitored through the collection of health-status changes and adverse-event occurrences during the 8-week study
AEs were recorded with date of onset and resolution, intensity, and relationship to study medication. The safety analysis was conducted on the intention-to-treat population, including all subjects assigned through randomization to treatment with oxytocin or placebo.
|
Additional Information
Egilius L.H. Spierings, M.D., Ph.D.
MedVadis Research Corporation
Phone: 781-588-5430
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place