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Completed

NCT Number: NCT01389102

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

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

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Alabama Clinical Therapeutics, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 spray, two 90 μL sprays

Drug

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 three 90 μL sprays

Drug

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

Placebo transdermal two 90 μL sprays

Drug

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 three 90 μL sprays

Drug

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 one 90 μL spray

Drug

Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

Primary outcomes

  1. Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day

    Time frame: baseline to week 12

    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

  2. Mean Change the Severity of Moderate to Severe Vasomotor Symptoms

    Time frame: baseline to week 12 (12 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Lumara Health, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 7, 2011
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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