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

July 5, 2011
June 8, 2012
December 2004
November 2006   (final data collection date for primary outcome measure)
  • Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]

    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

  • Mean Change the Severity of Moderate to Severe Vasomotor Symptoms [ Time Frame: baseline to week 12 (12 weeks) ] [ Designated as safety issue: No ]

    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.

  • Mean change in severity of moderate to severe vasomotor symptoms [ Time Frame: baseline to week 12 (12 weeks) ] [ Designated as safety issue: No ]

    Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms [hot flushes and sweating] experienced each day.

    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

  • Mean change in severity of moderate to severe vasomotor symptoms [ Time Frame: baseline to week 12 (12 weeks) ] [ Designated as safety issue: No ]

    Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms [hot flushes and sweating] experienced each day.

    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

    The severity of moderate to severe hot flushes was calculated using the severity score of moderate to severe hot flushes:

    (2 x # moderate + 3 x # severe) / (# moderate + # severe)

Complete list of historical versions of study NCT01389102 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hot Flashes
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
    Intervention: Drug: Placebo transdermal three 90 μL sprays
  • 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
    Intervention: Drug: Placebo transdermal two 90 μL sprays
  • 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
    Intervention: Drug: Placebo transdermal one 90 μL spray
  • 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
    Intervention: Drug: Estradiol transdermal three 90 μL sprays
  • 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
    Intervention: Drug: Estradiol transdermal spray, two 90 μL sprays
  • 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
    Intervention: Drug: Estradiol transdermal one 90 μL spray
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
454
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Female
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01389102
EST-01
No
Lumara Health, Inc.
Lumara Health, Inc.
Not Provided
Not Provided
Lumara Health, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP