Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes

NCT00206622 ↗

Phase 4 Completed 425 enrolled Bayer

RandomizedParallel-groupDouble-blindTreatment

Summary

To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women

Timeline

Start: 2004-12
Primary completion: —
Completion: 2006-02

Publications

Bachmann GA, Schaefers M, Uddin A, Utian WH. Lowest effective transdermal 17beta-estradiol dose for relief of hot flushes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Oct;110(4):771-9. doi: 10.1097/01.AOG.0000284450.51264.31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Estradiol	Other / unclassified	1 mg	Other
Comparator	Estradiol	Other / unclassified	2.2 mg	Other
Comparator	Levonorgestrel	Small molecule	0.69 mg	Other

Indications

No indication recorded.