Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

• Sponsor: Lumara Health, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01389102
• Collaborator: (none)
• Enrollment: 454
• Locations: 43
• Arms: 6
• Duration (Months): 23
• Patients Per Site: 10.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.

Condition or Disease	Intervention/Treatment	Phase
Hot Flashes	Drug: Estradiol transdermal one 90 μL spray; Drug: Estradiol transdermal spray, two 90 μL sprays; Drug: Estradiol transdermal three 90 μL sprays; Drug: Placebo transdermal two 90 μL sprays; Drug: Placebo transdermal three 90 μL sprays; Drug: Placebo transdermal one 90 μL spray	Phase 3

Detailed Description

Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 454 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	Drug: 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 Comparator: 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	Drug: 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 Comparator: 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	Drug: 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
Active Comparator: 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	Drug: 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
Active Comparator: 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	Drug: Estradiol transdermal spray, 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
Active Comparator: 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	Drug: 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

Outcome Measures

Primary Outcome Measures

1. Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day [baseline to week 12]

   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

2. Mean Change the Severity of Moderate to Severe Vasomotor Symptoms [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Post menopausal women,

• Ages 35 or older,

• Frequent moderate to severe hot flushes,

• Qualifying general medical health

Exclusion Criteria:

• Disqualifying gynecological disorders,

• Disqualifying dermatological disorders,

• Disqualifying concurrent conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Clinical Therapeutics	Birmingham	Alabama	United States	35235
2	Costal Clinical Research	Mobile	Alabama	United States	36608
3	Harmony Clinic	Oro Valley	Arizona	United States	85739
4	Hope Research Institute	Phoenix	Arizona	United States	85032
5	Radiant Research	Phoenix	Arizona	United States	85032
6	Radiant Research	Tucson	Arizona	United States	85701
7	NEA Womens Clinic	Jonesboro	Arkansas	United States	72401
8	Arkansas Women's Center	Little Rock	Arkansas	United States	72205
9	Speciality Care for Women	Redding	California	United States	96001
10	Sacramento Research Medical Grp	Sacramento	California	United States	95825
11	Dr. Steven Drosman	San Diego	California	United States	92103
12	Medical Center for Clinical Research	San Diego	California	United States	92108
13	Benchmark Research	San Francisco	California	United States	94102
14	Pacific Clinical Research	Santa Monica	California	United States	90404
15	Diablo Clinical Research	Walnut Creek	California	United States	94598
16	Downtown Women's Health Care	Denver	Colorado	United States	80202
17	South Florida Medical Research	Aventura	Florida	United States	33180
18	Renstar Medical Research	Ocala	Florida	United States	34471
19	Radiant Research	Pinellas Park	Florida	United States	33781
20	Comprehensive Clinical Trials	West Palm Beach	Florida	United States	33409
21	Radiant Research	Atlanta	Georgia	United States	30342
22	Atlanta West Women's Center	Douglasville	Georgia	United States	30134
23	Radiant Research	Chicago	Illinois	United States	60610
24	Benchmark Research	Metairie	Louisiana	United States	70002
25	Clinical Trials Management	Metairie	Louisiana	United States	70006
26	Women's Health Research Ctr.	Laurel	Maryland	United States	20707
27	Ridgeview Research	Chaska	Minnesota	United States	55318
28	Meridian Clinical Research	Omaha	Nebraska	United States	68134
29	Mid Dakota Clinic	Bismark	North Dakota	United States	58501
30	Radiant Research	Cincinnati	Ohio	United States	45236
31	Radiant Research	Columbus	Ohio	United States	43212
32	TriPhase Research	Franklin	Ohio	United States	45005
33	Radiant Research	Mogadore	Ohio	United States	44260
34	PMG-South/OB-Gyn Health Ctr.	Medford	Oregon	United States	97504
35	Center for Women's Medicine	Greenville	South Carolina	United States	29605
36	Clinical Research Associates	Nashville	Tennessee	United States	37203
37	Benchmark Research	Austin	Texas	United States	78705
38	Advanced Research Associates	Corpus Christi	Texas	United States	78414
39	Baylor College of Medicine	Houston	Texas	United States	77033
40	Radiant Research	San Antonio	Texas	United States	78229
41	J. Lewis Research	Salt Lake City	Utah	United States	84109
42	University of Eastern Virginia	Norfold	Virginia	United States	23507
43	Tacoma Women's Specialists	Tacoma	Washington	United States	98405

Sponsors and Collaborators

• Lumara Health, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lumara Health, Inc.
• ClinicalTrials.gov Identifier: NCT01389102
• Other Study ID Numbers: EST-01; NCT00122200
• First Posted: Jul 7, 2011
• Last Update Posted: Jun 11, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Lumara Health, Inc.: Postmenopause; Hot Flashes; Estradiol; Polyestradiol phosphate; Estradiol valerate; Estradiol 3-benzoate; Estradiol 17 beta-cypionate; Estrogens; Hormones; Hormones, Hormone Substitutes; Hormone Antagonists
• Additional relevant MeSH terms: Hot Flashes; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 43 physicians' offices, or their affiliated locations, within the United States between 17 December 2004 and 09 March 2006
Pre-assignment Detail	Participants underwent a four week screening period to determine eligibility prior to assignment into the study.

Arm/Group Title	Placebo Transdermal Three 90 μL Sprays	Placebo Transdermal Two 90 μL Sprays	Placebo Transdermal One 90 μL Spray	Estradiol Transdermal Three 90 μL Sprays	Estradiol Transdermal Two 90 μL Sprays	Estradiol Transdermal One 90 μL Spray
Arm/Group Description	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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Period Title: Overall Study
STARTED	75	76	77	76	74	76
COMPLETED	57	64	58	69	61	68
NOT COMPLETED	18	12	19	7	13	8

Baseline Characteristics

Arm/Group Title	Placebo Transdermal Three 90 μL Sprays	Placebo Transdermal Two 90 μL Sprays	Placebo Transdermal One 90 μL Spray	Estradiol Transdermal Three 90 μL Sprays	Estradiol Transdermal Two 90 μL Sprays	Estradiol Transdermal One 90 μL Spray	Total
Arm/Group Description	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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Total of all reporting groups
Overall Participants	75	76	77	76	74	76	454
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.0 (6.3)	52.0 (7.0)	52.8 (6.9)	52.3 (5.7)	52.2 (6.8)	53.5 (6.8)	52.7 (6.5)
Sex: Female, Male (Count of Participants)
Female	75 100%	76 100%	77 100%	76 100%	74 100%	76 100%	454 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day
Description	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
Time Frame	baseline to week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Transdermal Three 90 μL Sprays	Placebo Transdermal Two 90 μL Sprays	Placebo Transdermal One 90 μL Spray	Estradiol Transdermal Three 90 μL Sprays	Estradiol Transdermal Two 90 μL Sprays	Estradiol Transdermal One 90 μL Spray
Arm/Group Description
Measure Participants	75	76	77	76	74	76
Mean (Standard Deviation) [Vasomotor symptoms per day]	-5.32 (6.30)	-6.19 (5.77)	-4.76 (5.84)	-8.44 (4.50)	-8.66 (6.65)	-8.10 (4.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo Transdermal Three 90 μL Sprays, Estradiol Transdermal Three 90 μL Sprays
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Transdermal Two 90 μL Sprays, Estradiol Transdermal Two 90 μL Sprays
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0099
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Estradiol Transdermal One 90 μL Spray
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Mean Change the Severity of Moderate to Severe Vasomotor Symptoms
Description	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.
Time Frame	baseline to week 12 (12 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Transdermal Three 90 μL Sprays	Placebo Transdermal Two 90 μL Sprays	Placebo Transdermal One 90 μL Spray	Estradiol Transdermal Three 90 μL Sprays	Estradiol Transdermal Two 90 μL Sprays	Estradiol Transdermal One 90 μL Spray
Arm/Group Description	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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Measure Participants	75	76	77	76	74	76
Mean (Standard Deviation) [Scores on a scale]	-0.31 (0.75)	-0.54 (0.89)	-0.26 (0.60)	-1.07 (1.01)	-0.92 (1.01)	-1.04 (1.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo Transdermal Three 90 μL Sprays, Estradiol Transdermal Three 90 μL Sprays
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo Transdermal Two 90 μL Sprays, Estradiol Transdermal Two 90 μL Sprays
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0406
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo Transdermal One 90 μL Spray, Estradiol Transdermal One 90 μL Spray
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	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.
Arm/Group Title	Placebo Transdermal Three 90 μL Sprays		Placebo Transdermal Two 90 μL Sprays		Placebo Transdermal One 90 μL Spray		Estradiol Transdermal Three 90 μL Sprays		Estradiol Transdermal Two 90 μL Sprays		Estradiol Transdermal One 90 μL Spray
Arm/Group Description	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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator		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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
All Cause Mortality
	Placebo Transdermal Three 90 μL Sprays		Placebo Transdermal Two 90 μL Sprays		Placebo Transdermal One 90 μL Spray		Estradiol Transdermal Three 90 μL Sprays		Estradiol Transdermal Two 90 μL Sprays		Estradiol Transdermal One 90 μL Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Transdermal Three 90 μL Sprays		Placebo Transdermal Two 90 μL Sprays		Placebo Transdermal One 90 μL Spray		Estradiol Transdermal Three 90 μL Sprays		Estradiol Transdermal Two 90 μL Sprays		Estradiol Transdermal One 90 μL Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/76 (0%)		1/77 (1.3%)		3/76 (3.9%)		1/74 (1.4%)		3/76 (3.9%)
Cardiac disorders
Palpitations	0/75 (0%)	0	0/76 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	0/74 (0%)	0	0/76 (0%)	0
Gastrointestinal disorders
Impaired Gastric Emptying	0/75 (0%)	0	0/76 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/74 (0%)	0	0/76 (0%)	0
General disorders
Chest Pain	0/75 (0%)	0	0/76 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/74 (0%)	0	0/76 (0%)	0
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis	0/75 (0%)	0	0/76 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	1/74 (1.4%)	1	0/76 (0%)	0
Nervous system disorders
Dizziness	0/75 (0%)	0	0/76 (0%)	0	1/77 (1.3%)	1	0/76 (0%)	0	0/74 (0%)	0	0/76 (0%)	0
Reproductive system and breast disorders
Uterine Prolapse	0/75 (0%)	0	0/76 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	0/74 (0%)	0	1/76 (1.3%)	1
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease Excerbated	0/75 (0%)	0	0/76 (0%)	0	0/77 (0%)	0	1/76 (1.3%)	1	0/74 (0%)	0	1/76 (1.3%)	1
Dyspnea	0/75 (0%)	0	0/76 (0%)	0	0/77 (0%)	0	0/76 (0%)	0	0/74 (0%)	0	1/76 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Placebo Transdermal Three 90 μL Sprays		Placebo Transdermal Two 90 μL Sprays		Placebo Transdermal One 90 μL Spray		Estradiol Transdermal Three 90 μL Sprays		Estradiol Transdermal Two 90 μL Sprays		Estradiol Transdermal One 90 μL Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/75 (17.3%)		18/76 (23.7%)		12/77 (15.6%)		21/76 (27.6%)		29/74 (39.2%)		21/76 (27.6%)
Gastrointestinal disorders
Nausea	4/75 (5.3%)		1/76 (1.3%)		5/77 (6.5%)		2/76 (2.6%)		2/74 (2.7%)		1/76 (1.3%)
Infections and infestations
Nasopharyngitis	1/75 (1.3%)		2/76 (2.6%)		1/77 (1.3%)		1/76 (1.3%)		3/74 (4.1%)		4/76 (5.3%)
Musculoskeletal and connective tissue disorders
Back pain	1/75 (1.3%)		2/76 (2.6%)		1/77 (1.3%)		2/76 (2.6%)		4/74 (5.4%)		2/76 (2.6%)
Arthralgia	0/75 (0%)		4/76 (5.3%)		1/77 (1.3%)		3/76 (3.9%)		1/74 (1.4%)		1/76 (1.3%)
Nervous system disorders
Headache	7/75 (9.3%)		5/76 (6.6%)		4/77 (5.2%)		8/76 (10.5%)		9/74 (12.2%)		7/76 (9.2%)
Reproductive system and breast disorders
Breast Tenderness	0/75 (0%)		4/76 (5.3%)		0/77 (0%)		4/76 (5.3%)		5/74 (6.8%)		4/76 (5.3%)
Nipple Pain	0/75 (0%)		0/76 (0%)		0/77 (0%)		1/76 (1.3%)		5/74 (6.8%)		2/76 (2.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.