Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT01389102
First received: July 5, 2011
Last updated: June 8, 2012
Last verified: June 2012
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
  Show All Outcome Measures

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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:
unchecked 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.
unchecked 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.


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 Lumara Health, Inc.

Publications automatically indexed to this study:

Responsible Party: Lumara Health, Inc.
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