Trial Outcomes & Findings for Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms (NCT NCT01389102)

Last Updated: 2012-06-11

Results Overview

Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms \[hot flushes and sweating\] experienced each day. Mild, moderate and severe hot flushes and sweating were defined as follows: Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

454 participants

Primary outcome timeframe

baseline to week 12

Results posted on

2012-06-11

Participant Flow

Participants were recruited from 43 physicians' offices, or their affiliated locations, within the United States between 17 December 2004 and 09 March 2006

Participants underwent a four week screening period to determine eligibility prior to assignment into the study.

Participant milestones

Participant milestones
Measure	Placebo Transdermal Three 90 μL Sprays Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal Two 90 μL Sprays Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal One 90 μL Spray Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Three 90 μL Sprays Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Two 90 μL Sprays Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal One 90 μL Spray Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Overall Study STARTED	75	76	77	76	74	76
Overall Study COMPLETED	57	64	58	69	61	68
Overall Study NOT COMPLETED	18	12	19	7	13	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Transdermal Three 90 μL Sprays Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal Two 90 μL Sprays Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal One 90 μL Spray Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Three 90 μL Sprays Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Two 90 μL Sprays Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal One 90 μL Spray Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Overall Study Adverse Event	1	3	2	2	2	2
Overall Study Hurricane Katrina	4	2	3	0	3	1
Overall Study Lost to Follow-up	4	1	1	2	4	1
Overall Study Protocol Violation	0	0	3	0	1	1
Overall Study Withdrawal by Subject	7	4	9	2	3	3
Overall Study Subject Traveling Out of Country	0	0	0	1	0	0
Overall Study Subject Moved	2	0	1	0	0	0
Overall Study Unavailable due to husband's illness	0	1	0	0	0	0
Overall Study Investigator Judgement	0	1	0	0	0	0

Baseline Characteristics

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Transdermal Three 90 μL Sprays n=75 Participants Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal Two 90 μL Sprays n=76 Participants Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal One 90 μL Spray n=77 Participants Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Three 90 μL Sprays n=76 Participants Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Two 90 μL Sprays n=74 Participants Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal One 90 μL Spray n=76 Participants Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Total n=454 Participants Total of all reporting groups
Age Continuous	52.0 years STANDARD_DEVIATION 6.3 • n=5 Participants	52.0 years STANDARD_DEVIATION 7.0 • n=7 Participants	52.8 years STANDARD_DEVIATION 6.9 • n=5 Participants	52.3 years STANDARD_DEVIATION 5.7 • n=4 Participants	52.2 years STANDARD_DEVIATION 6.8 • n=21 Participants	53.5 years STANDARD_DEVIATION 6.8 • n=10 Participants	52.7 years STANDARD_DEVIATION 6.5 • n=115 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	76 Participants n=7 Participants	77 Participants n=5 Participants	76 Participants n=4 Participants	74 Participants n=21 Participants	76 Participants n=10 Participants	454 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: baseline to week 12

Outcome measures

Outcome measures
Measure	Placebo Transdermal Three 90 μL Sprays n=75 Participants	Placebo Transdermal Two 90 μL Sprays n=76 Participants	Placebo Transdermal One 90 μL Spray n=77 Participants	Estradiol Transdermal Three 90 μL Sprays n=76 Participants	Estradiol Transdermal Two 90 μL Sprays n=74 Participants	Estradiol Transdermal One 90 μL Spray n=76 Participants
Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day	-5.32 Vasomotor symptoms per day Standard Deviation 6.30	-6.19 Vasomotor symptoms per day Standard Deviation 5.77	-4.76 Vasomotor symptoms per day Standard Deviation 5.84	-8.44 Vasomotor symptoms per day Standard Deviation 4.50	-8.66 Vasomotor symptoms per day Standard Deviation 6.65	-8.10 Vasomotor symptoms per day Standard Deviation 4.02

PRIMARY outcome

Timeframe: baseline to week 12 (12 weeks)

Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day. Mild, moderate and severe were defined as follows: Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3.

Outcome measures

Outcome measures
Measure	Placebo Transdermal Three 90 μL Sprays n=75 Participants	Placebo Transdermal Two 90 μL Sprays n=76 Participants	Placebo Transdermal One 90 μL Spray n=77 Participants	Estradiol Transdermal Three 90 μL Sprays n=76 Participants	Estradiol Transdermal Two 90 μL Sprays n=74 Participants	Estradiol Transdermal One 90 μL Spray n=76 Participants
Mean Change the Severity of Moderate to Severe Vasomotor Symptoms	-0.31 Scores on a scale Standard Deviation 0.75	-0.54 Scores on a scale Standard Deviation 0.89	-0.26 Scores on a scale Standard Deviation 0.60	-1.07 Scores on a scale Standard Deviation 1.01	-0.92 Scores on a scale Standard Deviation 1.01	-1.04 Scores on a scale Standard Deviation 1.01

Adverse Events

Placebo Transdermal Three 90 μL Sprays

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo Transdermal Two 90 μL Sprays

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo Transdermal One 90 μL Spray

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Estradiol Transdermal Three 90 μL Sprays

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Estradiol Transdermal Two 90 μL Sprays

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Estradiol Transdermal One 90 μL Spray

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Transdermal Three 90 μL Sprays n=75 participants at risk Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal Two 90 μL Sprays n=76 participants at risk Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal One 90 μL Spray n=77 participants at risk Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Three 90 μL Sprays n=76 participants at risk Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Two 90 μL Sprays n=74 participants at risk Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal One 90 μL Spray n=76 participants at risk Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Nervous system disorders Dizziness	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/77 • Number of events 1 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Reproductive system and breast disorders Uterine Prolapse	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • Number of events 1 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Gastrointestinal disorders Impaired Gastric Emptying	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • Number of events 1 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.4% 1/74 • Number of events 1 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
General disorders Chest Pain	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • Number of events 1 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Airways Disease Excerbated	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • Number of events 1 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • Number of events 1 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Cardiac disorders Palpitations	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • Number of events 1 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.

Other adverse events

Other adverse events
Measure	Placebo Transdermal Three 90 μL Sprays n=75 participants at risk Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal Two 90 μL Sprays n=76 participants at risk Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Placebo Transdermal One 90 μL Spray n=77 participants at risk Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Three 90 μL Sprays n=76 participants at risk Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal Two 90 μL Sprays n=74 participants at risk Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol Transdermal One 90 μL Spray n=76 participants at risk Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Infections and infestations Nasopharyngitis	1.3% 1/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	2.6% 2/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	4.1% 3/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	5.3% 4/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Nervous system disorders Headache	9.3% 7/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	6.6% 5/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	5.2% 4/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	10.5% 8/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	12.2% 9/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	9.2% 7/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Reproductive system and breast disorders Breast Tenderness	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	5.3% 4/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	5.3% 4/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	6.8% 5/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	5.3% 4/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Reproductive system and breast disorders Nipple Pain	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	0.00% 0/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	6.8% 5/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	2.6% 2/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Gastrointestinal disorders Nausea	5.3% 4/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	6.5% 5/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	2.6% 2/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	2.7% 2/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Musculoskeletal and connective tissue disorders Back pain	1.3% 1/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	2.6% 2/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	2.6% 2/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	5.4% 4/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	2.6% 2/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/75 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	5.3% 4/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/77 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	3.9% 3/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.4% 1/74 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.	1.3% 1/76 • 12 weeks Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.

Additional Information

Jim Joffrion

KV Pharmaceutical Company

Phone: 314-645-6600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator shall not publish, or seek to publish, either in whole or in part, any results of the Clinical Investigation without the written consent of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER