Phase 3
Completed N=454
Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
Hot Flashes
Source: ClinicalTrials.gov NCT01389102 ↗
Enrolled (actual)
454
Serious AEs
1.8%
Results posted
Jun 2012
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.