Phase 3
N=454
Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT01389102 ↗Enrolled (actual)
454
Serious AEs
1.8%
Results posted
Jun 2012
Primary outcome: Primary: Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day — -5.32; -6.19; -4.76; -8.44 Vasomotor symptoms per day — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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 (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Lumara Health, Inc.
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day |
-5.32; -6.19; -4.76; -8.44; -8.66; -8.10 | <0.0001 sig |
| PRIMARY Mean Change the Severity of Moderate to Severe Vasomotor Symptoms |
-0.31; -0.54; -0.26; -1.07; -0.92; -1.04 | <0.0001 sig |
Summary
Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01389102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.