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

Phase 4

Completed

• Conditions: Postmenopausal Symptoms
• Interventions: Other: Placebo; Drug: Estrogel

• Registration Number: NCT00160173
• Lead Sponsor: ASCEND Therapeutics

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2004-12-02
• Primary Completion: 2005-09-06
• Study Completion: 2005-09-06
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Gel	Placebo	0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
EstroGel® Gel 0.9 grams 0.03%	Estrogel	0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
EstroGel® Gel 1.25 grams 0.03%	Estrogel	1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks.

Trial Locations

Locations (109)

Site 112; 🇺🇸 Birmingham, Alabama, United States

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

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