Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

KV Pharmaceutical Company

ClinicalTrials.gov Identifier:

NCT01389102

First received: July 5, 2011

Last updated: June 8, 2012

Last verified: June 2012

History of Changes

Results First Received: February 29, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hot Flashes
Interventions:	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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants underwent a four week screening period to determine eligibility prior to assignment into the study.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	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
STARTED	75	76	77	76	74	76
COMPLETED	57	64	58	69	61	68
NOT COMPLETED	18	12	19	7	13	8
Adverse Event	1	3	2	2	2	2
Hurricane Katrina	4	2	3	0	3	1
Lost to Follow-up	4	1	1	2	4	1
Protocol Violation	0	0	3	0	1	1
Withdrawal by Subject	7	4	9	2	3	3
Subject Traveling Out of Country	0	0	0	1	0	0
Subject Moved	2	0	1	0	0	0
Unavailable due to husband's illness	0	1	0	0	0	0
Investigator Judgement	0	1	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

	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
Number of Participants [units: participants]	75	76	77	76	74	76	454
Age [units: years] Mean ± Standard Deviation	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
Gender [units: participants]
Female	75	76	77	76	74	76	454
Male	0	0	0	0	0	0	0

Outcome Measures

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1. Primary:

Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day [ Time Frame: baseline to week 12 ]

Show Outcome Measure 1

2. Primary:

Mean Change the Severity of Moderate to Severe Vasomotor Symptoms [ Time Frame: baseline to week 12 (12 weeks) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Jim Joffrion
Organization: KV Pharmaceutical Company
phone: 314-645-6600 ext 3410
e-mail: jjoffrion@kvph.com

No publications provided by KV Pharmaceutical Company

Publications automatically indexed to this study:

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.

Responsible Party:	KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT01389102 History of Changes
Obsolete Identifiers:	NCT00122200
Other Study ID Numbers:	EST-01
Study First Received:	July 5, 2011
Results First Received:	February 29, 2012
Last Updated:	June 8, 2012
Health Authority:	United States: Food and Drug Administration

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