Multi-Center Study to Evaluate Estradiol Transdermal Spray in the Treatment of Symptomatic Postmenopausal Women

Condition(s) targeted: Hot Flashes

Intervention: Topical estradiol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: VIVUS, Inc.

Official(s) and/or principal investigator(s):
Sam Teichman, MD, Study Director, Affiliation: Vivus Clinical Research Department

Estradiol treatment is effective at reducing vasomotor symptoms (eg, hot flushes) in postmenopausal women. Vivus has a proprietary spray delivery system (Evamist) for estradiol. This study will evaluate the safety and efficacy of this product.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Incidence and severity of hot flushes

Safety

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by spray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal 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

University of Eastern Virginia, Norfolk, Virginia 23507, United States

prequalification questionnaire for patients

Starting date: December 2004
Ending date: November 2006
Last updated: June 14, 2007