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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Lumara Health, Inc.:

Primary Outcome Measures:
  • 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.



Enrollment: 454
Study Start Date: December 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389102

  Show 43 Study Locations
Sponsors and Collaborators
Lumara Health, Inc.
  More Information

No publications provided by Lumara Health, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Hormone Antagonists
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 27, 2014