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OpenTrials
Completed

NCT Number: NCT00160173

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

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

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Key information

Conditions

Postmenopausal Symptoms

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Site 112, Birmingham, Alabama, United States

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About this study

The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women 45-65 years
  • naturally or surgically postmenopausal
  • experiencing hot flushes

Exclusion criteria

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

Treatment and study plan

Estrogel

Drug

Placebo

Other

Sponsors and collaborators

Lead sponsor

ASCEND Therapeutics

Industry

Collaborators

  • Solvay Pharmaceuticals

Registry information

Official study title

Efficacy Study Comparing 0.9 g and 1.25 g EstroGel® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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