Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Phase 3 Completed 454 enrolled Lumara Health, Inc.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2004-12
Primary completion: 2006-11
Completion: 2006-11

Publications

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. doi: 10.1097/AOG.0b013e318175d162.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Estradiol	Other / unclassified	1.53 mg	Other
Comparator	Estradiol	Other / unclassified	3.06 mg	Other
Comparator	Estradiol	Other / unclassified	4.59 mg	Other

Indications

No indication recorded.