Estradiol Transdermal Spray in the Treatment of Vasomotor... | NCT01389102

NCT01389102

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo transdermal three 90 μL sprays	Placebo Comparator	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 two 90 μL sprays	Placebo Comparator	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 one 90 μL spray	Placebo Comparator	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
Estradiol transdermal three 90 μL sprays	Active Comparator	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 two 90 μL sprays	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Estradiol transdermal one 90 μL spray	Drug	Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Estradiol transdermal one 90 μL spray

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day	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	baseline to week 12
Mean Change the Severity of Moderate to Severe Vasomotor Symptoms	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.	baseline to week 12 (12 weeks)

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Clinical Therapeutics		Birmingham	Alabama	35235	United States
Costal Clinical Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18515518	Derived	Buster JE, Koltun WD, Pascual ML, Day WW, Peterson C. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1343-51. doi: 10.1097/AOG.0b013e318175d162.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Placebo Transdermal Two 90 μL Sprays

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	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
BG003	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
BG004	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
BG005	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
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-5.32± 6.30 OG001-6.19± 5.77 OG002-4.76± 5.84 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		ANCOVA		<0.0001							95						No	Superiority or Other
OG001 OG004		ANCOVA		0.0099

Primary

Mean Change the Severity of Moderate to Severe Vasomotor Symptoms

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.

Posted

Mean

Standard Deviation

Scores on a scale

baseline to week 12 (12 weeks)

ID	Title	Description
OG000	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
OG001	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
OG002	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

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	75	13	75
EG001	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	0	76	18	76
EG002	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	1	77	12	77
EG003	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	3	76	21	76
EG004	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	1	74	29	74
EG005	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	3	76	21	76

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dizziness	Nervous system disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected76 at risk EG0021 events1 affected77 at risk EG0030 events0 affected76 at risk EG0040 events0 affected74 at risk EG0050 events0 affected76 at risk
Uterine Prolapse	Reproductive system and breast disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected76 at risk EG0020 events0 affected77 at risk EG003
Impaired Gastric Emptying	Gastrointestinal disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected76 at risk EG0020 events0 affected77 at risk EG003
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected76 at risk EG0020 events0 affected77 at risk EG003
Chest Pain	General disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected76 at risk EG0020 events0 affected77 at risk EG003
Chronic Obstructive Airways Disease Excerbated	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected76 at risk EG0020 events0 affected77 at risk EG003
Palpitations	Cardiac disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected76 at risk EG0020 events0 affected77 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 events0 affected75 at risk EG0010 events0 affected76 at risk EG0020 events0 affected77 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (7.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0012 affected76 at risk EG0021 affected77 at risk EG0031 affected76 at risk EG0043 affected74 at risk EG0054 affected76 at risk
Headache	Nervous system disorders	MedDRA (7.1)	Non-systematic Assessment	EG0007 affected75 at risk EG0015 affected76 at risk EG0024 affected77 at risk EG003
Breast Tenderness	Reproductive system and breast disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0014 affected76 at risk EG0020 affected77 at risk EG003
Nipple Pain	Reproductive system and breast disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected76 at risk EG0020 affected77 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (7.1)	Non-systematic Assessment	EG0004 affected75 at risk EG0011 affected76 at risk EG0025 affected77 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0012 affected76 at risk EG0021 affected77 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0014 affected76 at risk EG0021 affected77 at risk EG003

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms