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

NCT00160173 | Completed Phase 4

• 1 other identifier: S166.4.003
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 109

Brief Summary

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

Conditions

Postmenopausal Symptoms

Keywords

Post menopausal vasomotor symptoms

Study Arms (3)

EstroGel® Gel 0.9 grams 0.03%

EXPERIMENTAL

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.

Drug: Estrogel

EstroGel® Gel 1.25 grams 0.03%

EXPERIMENTAL

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.

Drug: Estrogel

Placebo Gel

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Estrogel DRUG

EstroGel® Gel 0.9 grams 0.03%; EstroGel® Gel 1.25 grams 0.03%

Placebo OTHER

Placebo Gel

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ASCEND Therapeutics: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (109)

Site 112

Birmingham, Alabama, United States

Location

Site 74

Mobile, Alabama, United States

Location

Site 20

Montgomery, Alabama, United States

Location

Site 34

Tucson, Arizona, United States

Location

Site 68

Tucson, Arizona, United States

Location

Site 5

Jonesboro, Arkansas, United States

Location

Site 88

Little Rock, Arkansas, United States

Location

Site 95

Little Rock, Arkansas, United States

Location

Site 104

Carmichael, California, United States

Location

Site 42

Encinitas, California, United States

Location

Site 21

San Diego, California, United States

Location

Site 37

San Diego, California, United States

Location

Site 78

San Diego, California, United States

Location

Site 82

San Diego, California, United States

Location

Site 69

Avon, Connecticut, United States

Location

Site 58

Bridgeport, Connecticut, United States

Location

Site 3

Groton, Connecticut, United States

Location

Site 72

Hartford, Connecticut, United States

Location

Site 54

New Britain, Connecticut, United States

Location

Site 79

Southport, Connecticut, United States

Location

Site 18

Waterbury, Connecticut, United States

Location

Site 97

West Hartford, Connecticut, United States

Location

Site 35

Aventura, Florida, United States

Location

Site 36

Aventura, Florida, United States

Location

Site 105

Clearwater, Florida, United States

Location

Site 49

Clearwater, Florida, United States

Location

Site 91

Daytona Beach, Florida, United States

Location

Site 57

Melbourne, Florida, United States

Location

Site 109

Miami, Florida, United States

Location

Site 39

Pinellas Park, Florida, United States

Location

Site 107

Spring Hill, Florida, United States

Location

Site 100

Tampa, Florida, United States

Location

Site 77

West Palm Beach, Florida, United States

Location

Site 61

Alpharetta, Georgia, United States

Location

Site 81

Alpharetta, Georgia, United States

Location

Site 28

Atlanta, Georgia, United States

Location

Site 93

Atlanta, Georgia, United States

Location

Site 55

Decatur, Georgia, United States

Location

Site 13

Douglasville, Georgia, United States

Location

Site 87

Powder Springs, Georgia, United States

Location

Site 22

Savannah, Georgia, United States

Location

Site 99

Savannah, Georgia, United States

Location

Site 53

Boise, Idaho, United States

Location

Site 96

Champaign, Illinois, United States

Location

Site 24

Chicago, Illinois, United States

Location

Site 84

Chicago, Illinois, United States

Location

Site 26

Peoria, Illinois, United States

Location

Site 46

Peoria, Illinois, United States

Location

Site 75

Evansville, Indiana, United States

Location

Site 45

South Bend, Indiana, United States

Location

Site 8

Waterloo, Iowa, United States

Location

Site 108

Lexington, Kentucky, United States

Location

Site 50

Baton Rouge, Louisiana, United States

Location

Site 12

Metairie, Louisiana, United States

Location

Site 65

New Orleans, Louisiana, United States

Location

Site 16

Shreveport, Louisiana, United States

Location

Site 11

Baltimore, Maryland, United States

Location

Site 66

Ann Arbor, Michigan, United States

Location

Site 15

Chaska, Minnesota, United States

Location

Site 29

Creve Coeur, Missouri, United States

Location

Site 2

St Louis, Missouri, United States

Location

Site 67

St Louis, Missouri, United States

Location

Site 19

Billings, Montana, United States

Location

Site 56

Lincoln, Nebraska, United States

Location

Site 6

Las Vegas, Nevada, United States

Location

Site 40

Reno, Nevada, United States

Location

Site102

Olean, New York, United States

Location

Site 31

Fayetteville, North Carolina, United States

Location

Site 60

New Bern, North Carolina, United States

Location

Site 59

Raleigh, North Carolina, United States

Location

Site 38

Winston-Salem, North Carolina, United States

Location

Site 70

Winston-Salem, North Carolina, United States

Location

Site 85

Winston-Salem, North Carolina, United States

Location

Site 86

Cincinnati, Ohio, United States

Location

Site 101

Edmond, Oklahoma, United States

Location

Site 89

Eugene, Oregon, United States

Location

Site 111

Medford, Oregon, United States

Location

Site 64

Portland, Oregon, United States

Location

Site 113

Erie, Pennsylvania, United States

Location

Site 98

Pottstown, Pennsylvania, United States

Location

Site 33

Greenville, South Carolina, United States

Location

Site 9

Chattanooga, Tennessee, United States

Location

Site 92

Memphis, Tennessee, United States

Location

Site 76

Nashville, Tennessee, United States

Location

Site 83

Carrollton, Texas, United States

Location

Site 17

Conroe, Texas, United States

Location

Site 23

Corpus Christi, Texas, United States

Location

Site 25

Corpus Christi, Texas, United States

Location

Site 30

Dallas, Texas, United States

Location

Site 90

Dallas, Texas, United States

Location

Site 10

Houston, Texas, United States

Location

Site 110

Houston, Texas, United States

Location

Site 14

Houston, Texas, United States

Location

Site 27

Houston, Texas, United States

Location

Site 48

Houston, Texas, United States

Location

Site 51

Houston, Texas, United States

Location

Site 71

Houston, Texas, United States

Location

Site 73

Houston, Texas, United States

Location

Site 43

San Antonio, Texas, United States

Location

Site 62

San Antonio, Texas, United States

Location

Site 80

San Antonio, Texas, United States

Location

Site 7

Texarkana, Texas, United States

Location

Site 44

Salt Lake City, Utah, United States

Location

Site 94

Salt Lake City, Utah, United States

Location

Site 47

Norfolk, Virginia, United States

Location

Site 106

Richmond, Virginia, United States

Location

Site 41

Richmond, Virginia, United States

Location

Site 4

Seattle, Washington, United States

Location

Site 52

Tacoma, Washington, United States

Location

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Director Solvay

  Solvay Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 2, 2004
• Primary Completion: September 6, 2005
• Study Completion: September 6, 2005
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

US (109)