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

Completed · Phase 4 · Has a placebo group

Conditions studied: Postmenopausal Symptoms

In brief

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

Key facts

Study ID

NCT00160173

Run by

ASCEND Therapeutics

People needed

221

Starts

2004-12-02

Expected to finish

2005-09-06

Last updated by the study team

2022-09-13

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Site 74 — Mobile, Alabama, United States
• Site 20 — Montgomery, Alabama, United States
• Site 34 — Tucson, Arizona, United States
• Site 68 — Tucson, Arizona, United States
• Site 5 — Jonesboro, Arkansas, United States
• Site 88 — Little Rock, Arkansas, United States
• Site 95 — Little Rock, Arkansas, United States
• Site 104 — Carmichael, California, United States
• Site 42 — Encinitas, California, United States
• Site 21 — San Diego, California, United States
• Site 37 — San Diego, California, United States
• Site 78 — San Diego, California, United States
• Site 82 — San Diego, California, United States
• Site 69 — Avon, Connecticut, United States
• Site 58 — Bridgeport, Connecticut, United States
• Site 3 — Groton, Connecticut, United States
• Site 72 — Hartford, Connecticut, United States
• Site 54 — New Britain, Connecticut, United States
• Site 79 — Southport, Connecticut, United States
• Site 18 — Waterbury, Connecticut, United States
• Site 97 — West Hartford, Connecticut, United States
• Site 35 — Aventura, Florida, United States
• Site 36 — Aventura, Florida, United States
• Site 105 — Clearwater, Florida, United States
• Site 112 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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