Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy

This study has been completed.

Sponsors and Collaborators:	ASCEND Therapeutics Solvay Pharmaceuticals
Information provided by:	ASCEND Therapeutics
ClinicalTrials.gov Identifier:	NCT00160173

Purpose

This study is intended to establish the lowest effective dose of EstroGelÂ® for the treatment of vasomotor symptoms associated with menopause.

Condition	Intervention	Phase
Postmenopausal Symptoms	Drug: Estradiol	Phase IV

MedlinePlus related topics: Menopause

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy Study Comparing 0.9 g and 1.25 g EstroGelÂ® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

hypersensitivity to estrogen replacement therapy
pregnancy or lactating
abnormal PAP smear
history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160173

Sponsors and Collaborators

ASCEND Therapeutics

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Study ID Numbers:	S166.4.003
Study First Received:	September 8, 2005
Last Updated:	October 5, 2006
ClinicalTrials.gov Identifier:	NCT00160173
Health Authority:	United States: Food and Drug Administration

Keywords provided by ASCEND Therapeutics:

Post menopausal vasomotor symptoms

Study placed in the following topic categories:

Estradiol 3-benzoate
Estradiol valerate
Atrophy
Estradiol 17 beta-cypionate

Polyestradiol phosphate
Estradiol
Menopause

ClinicalTrials.gov processed this record on January 16, 2009