Postmenopausal Symptoms Clinical Trial
Official 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
| Verified date | September 2022 |
| Source | ASCEND Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
| Status | Completed |
| Enrollment | 221 |
| Est. completion date | September 6, 2005 |
| Est. primary completion date | September 6, 2005 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 61 | Alpharetta | Georgia |
| United States | Site 81 | Alpharetta | Georgia |
| United States | Site 66 | Ann Arbor | Michigan |
| United States | Site 28 | Atlanta | Georgia |
| United States | Site 93 | Atlanta | Georgia |
| United States | Site 35 | Aventura | Florida |
| United States | Site 36 | Aventura | Florida |
| United States | Site 69 | Avon | Connecticut |
| United States | Site 11 | Baltimore | Maryland |
| United States | Site 50 | Baton Rouge | Louisiana |
| United States | Site 19 | Billings | Montana |
| United States | Site 112 | Birmingham | Alabama |
| United States | Site 53 | Boise | Idaho |
| United States | Site 58 | Bridgeport | Connecticut |
| United States | Site 104 | Carmichael | California |
| United States | Site 83 | Carrollton | Texas |
| United States | Site 96 | Champaign | Illinois |
| United States | Site 15 | Chaska | Minnesota |
| United States | Site 9 | Chattanooga | Tennessee |
| United States | Site 24 | Chicago | Illinois |
| United States | Site 84 | Chicago | Illinois |
| United States | Site 86 | Cincinnati | Ohio |
| United States | Site 105 | Clearwater | Florida |
| United States | Site 49 | Clearwater | Florida |
| United States | Site 17 | Conroe | Texas |
| United States | Site 23 | Corpus Christi | Texas |
| United States | Site 25 | Corpus Christi | Texas |
| United States | Site 29 | Creve Coeur | Missouri |
| United States | Site 30 | Dallas | Texas |
| United States | Site 90 | Dallas | Texas |
| United States | Site 91 | Daytona Beach | Florida |
| United States | Site 55 | Decatur | Georgia |
| United States | Site 13 | Douglasville | Georgia |
| United States | Site 101 | Edmond | Oklahoma |
| United States | Site 42 | Encinitas | California |
| United States | Site 113 | Erie | Pennsylvania |
| United States | Site 89 | Eugene | Oregon |
| United States | Site 75 | Evansville | Indiana |
| United States | Site 31 | Fayetteville | North Carolina |
| United States | Site 33 | Greenville | South Carolina |
| United States | Site 3 | Groton | Connecticut |
| United States | Site 72 | Hartford | Connecticut |
| United States | Site 10 | Houston | Texas |
| United States | Site 110 | Houston | Texas |
| United States | Site 14 | Houston | Texas |
| United States | Site 27 | Houston | Texas |
| United States | Site 48 | Houston | Texas |
| United States | Site 51 | Houston | Texas |
| United States | Site 71 | Houston | Texas |
| United States | Site 73 | Houston | Texas |
| United States | Site 5 | Jonesboro | Arkansas |
| United States | Site 6 | Las Vegas | Nevada |
| United States | Site 108 | Lexington | Kentucky |
| United States | Site 56 | Lincoln | Nebraska |
| United States | Site 88 | Little Rock | Arkansas |
| United States | Site 95 | Little Rock | Arkansas |
| United States | Site 111 | Medford | Oregon |
| United States | Site 57 | Melbourne | Florida |
| United States | Site 92 | Memphis | Tennessee |
| United States | Site 12 | Metairie | Louisiana |
| United States | Site 109 | Miami | Florida |
| United States | Site 74 | Mobile | Alabama |
| United States | Site 20 | Montgomery | Alabama |
| United States | Site 76 | Nashville | Tennessee |
| United States | Site 60 | New Bern | North Carolina |
| United States | Site 54 | New Britain | Connecticut |
| United States | Site 65 | New Orleans | Louisiana |
| United States | Site 47 | Norfolk | Virginia |
| United States | Site102 | Olean | New York |
| United States | Site 26 | Peoria | Illinois |
| United States | Site 46 | Peoria | Illinois |
| United States | Site 39 | Pinellas Park | Florida |
| United States | Site 64 | Portland | Oregon |
| United States | Site 98 | Pottstown | Pennsylvania |
| United States | Site 87 | Powder Springs | Georgia |
| United States | Site 59 | Raleigh | North Carolina |
| United States | Site 40 | Reno | Nevada |
| United States | Site 106 | Richmond | Virginia |
| United States | Site 41 | Richmond | Virginia |
| United States | Site 2 | Saint Louis | Missouri |
| United States | Site 67 | Saint Louis | Missouri |
| United States | Site 44 | Salt Lake City | Utah |
| United States | Site 94 | Salt Lake City | Utah |
| United States | Site 43 | San Antonio | Texas |
| United States | Site 62 | San Antonio | Texas |
| United States | Site 80 | San Antonio | Texas |
| 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 22 | Savannah | Georgia |
| United States | Site 99 | Savannah | Georgia |
| United States | Site 4 | Seattle | Washington |
| United States | Site 16 | Shreveport | Louisiana |
| United States | Site 45 | South Bend | Indiana |
| United States | Site 79 | Southport | Connecticut |
| United States | Site 107 | Spring Hill | Florida |
| United States | Site 52 | Tacoma | Washington |
| United States | Site 100 | Tampa | Florida |
| United States | Site 7 | Texarkana | Texas |
| United States | Site 34 | Tucson | Arizona |
| United States | Site 68 | Tucson | Arizona |
| United States | Site 18 | Waterbury | Connecticut |
| United States | Site 8 | Waterloo | Iowa |
| United States | Site 97 | West Hartford | Connecticut |
| United States | Site 77 | West Palm Beach | Florida |
| United States | Site 38 | Winston-Salem | North Carolina |
| United States | Site 70 | Winston-Salem | North Carolina |
| United States | Site 85 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| ASCEND Therapeutics | Solvay Pharmaceuticals |
United States,
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06369363 -
Estrogen Deficiency on Cardiovascular Risk
|
Early Phase 1 | |
| Not yet recruiting |
NCT01170195 -
Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms
|
Phase 1/Phase 2 | |
| Completed |
NCT00535288 -
Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)
|
Phase 3 | |
| Recruiting |
NCT06030388 -
Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women
|
N/A | |
| Not yet recruiting |
NCT05557799 -
Photobiomodulation in Post Menopause Genitourinary Syndrome
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04893226 -
Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
|
N/A | |
| Completed |
NCT03684096 -
Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes
|
N/A | |
| Completed |
NCT01268046 -
Aging and Estrogen on Cortical Function
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05659693 -
The Effect of Digital Literacy Education Given to Postmenopausal Women on Health Literacy and Quality of Life
|
N/A | |
| Completed |
NCT03572153 -
A Mind-Body Intervention for Hot Flash Management
|
N/A | |
| Not yet recruiting |
NCT06419972 -
Multimodal Program for Climacteric Women
|
N/A | |
| Not yet recruiting |
NCT06197568 -
Open-Label Study of Vaginal AZU-101 in Postmenopausal Women
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03854396 -
Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women
|
Phase 3 | |
| Completed |
NCT01361308 -
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
|
Phase 3 | |
| Unknown status |
NCT00905723 -
The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
|
Phase 3 | |
| Recruiting |
NCT05351476 -
Exercise Training and Fat Metabolism in Postmenopausal Women
|
N/A | |
| Completed |
NCT06096818 -
Kegel and Abdominal Exercises on Urinary Incontinence Severity, Quality of Life, and Sleep Quality in Menopausal Women
|
N/A | |
| Completed |
NCT03150407 -
Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness
|
N/A | |
| Recruiting |
NCT06220266 -
Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04129060 -
Cholinergic Health After Menopause (CHAMP)
|
Early Phase 1 |