Hot Flashes Clinical Trial
Official title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women
| Verified date | July 2009 |
| Source | Teva Pharmaceutical Industries |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 30 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Naturally or surgically postmenopausal - At least 12 months since last menses or 6 weeks past surgery - Minimum of 7 daily or 50 weekly moderate to severe hot flashes Exclusion Criteria: - Any contraindication to natural or synthetic estrogens |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Duramed Investigational Site | Albuquerque | New Mexico |
| United States | Duramed Investigational Site | Alpharetta | Georgia |
| United States | Duramed Investigational Site | Baltimore | Maryland |
| United States | Duramed Investigational Site | Boise | Idaho |
| United States | Duramed Investigational Site | Bristol | Tennessee |
| United States | Duramed Investigational Site | Brooksville | Florida |
| United States | Duramed Investigational Site | Carmichael | California |
| United States | Duramed Investigational Site | Charleston | South Carolina |
| United States | Duramed Investigational Site | Clarksville | Tennessee |
| United States | Duramed Investigational Site | Cleveland | Ohio |
| United States | Duramed Investigational Site | Columbus | Ohio |
| United States | Duramed Investigational Site | Coral Gables | Florida |
| United States | Duramed Investigational Site | Dallas | Texas |
| United States | Duramed Investigational Site | Douglasville | Georgia |
| United States | Duramed Investigational Site | Evansville | Indiana |
| United States | Duramed Investigational Site | Fort Worth | Texas |
| United States | Duramed Investigational Site | Gainesville | Florida |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Houston | Texas |
| United States | Duramed Investigational Site | Huntsville | Alabama |
| United States | Duramed Investigational Site | Irvine | California |
| United States | Duramed Investigational Site | King of Prussia | Pennsylvania |
| United States | Duramed Investigational Site | Las Vegas | Nevada |
| United States | Duramed Investigational Site | Leesburg | Florida |
| United States | Duramed Investigational Site | Lexington | Kentucky |
| United States | Duramed Investigational Site | Lincoln | Nebraska |
| United States | Duramed Investigational Site | Mayfield Heights | Ohio |
| United States | Duramed Investigational Site | Medford | Oregon |
| United States | Duramed Investigational Site | Miami | Florida |
| United States | Duramed Investigational Site | Montgomery | Alabama |
| United States | Duramed Investigational Site | Nashville | Tennessee |
| United States | Duramed Investigational Site | Norfolk | Virginia |
| United States | Duramed Investigational Site | North Wales | Pennsylvania |
| United States | Duramed Investigational Site | Palm Springs | Florida |
| United States | Duramed Investigational Site | Philadelphia | Pennsylvania |
| United States | Duramed Investigational Site | Philadelphia | Pennsylvania |
| United States | Duramed Investigational Site | Phoenix | Arizona |
| United States | Duramed Investigational Site | Phoenix | Arizona |
| United States | Duramed Investigational Site | Pittsburgh | Pennsylvania |
| United States | Duramed Investigational Site | San Antonio | Texas |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | San Diego | California |
| United States | Duramed Investigational Site | San Ramon | California |
| United States | Duramed Investigational Site | Spokane | Washington |
| United States | Duramed Investigational Site | Tacoma | Washington |
| United States | Duramed Investigational Site | Tucson | Arizona |
| United States | Duramed Investigational Site | Venice | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Duramed Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in average frequency of moderate to severe hot flashes | Baseline to Day 28 and to Day 84 | No | |
| Primary | Mean change in severity of moderate to severe hot flashes | Baseline to Day 28 and to Day 84 | No | |
| Secondary | Safety and tolerability of Cenestin 0.3mg | Throughout study | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04587154 -
Womens Study to Alleviate Vasomotor Symptoms
|
N/A | |
| Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
| Completed |
NCT05061563 -
A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults
|
Phase 1 | |
| Completed |
NCT05419908 -
Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
|
Phase 2 | |
| Completed |
NCT01281332 -
Mechanical Device for the Relief of Hot Flashes
|
Phase 2 | |
| Completed |
NCT01439945 -
Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
|
Phase 2 | |
| Completed |
NCT00755417 -
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
|
Phase 3 | |
| Completed |
NCT01293695 -
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
|
N/A | |
| Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A | |
| Completed |
NCT00256685 -
Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
|
Phase 3 | |
| Completed |
NCT00391417 -
Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms
|
Phase 3 | |
| Terminated |
NCT00244894 -
Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
|
N/A | |
| Completed |
NCT00010712 -
Effects of Black Cohosh on Menopausal Hot Flashes
|
Phase 2 | |
| Active, not recruiting |
NCT03580499 -
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
|
N/A | |
| Recruiting |
NCT06030388 -
Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women
|
N/A | |
| Recruiting |
NCT04418115 -
Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option?
|
N/A | |
| Recruiting |
NCT04861701 -
Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise
|
N/A | |
| Active, not recruiting |
NCT05086705 -
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
|
N/A | |
| Completed |
NCT05099159 -
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)
|
Phase 3 | |
| Completed |
NCT01140646 -
Evaluation of SAMe for Hot Flashes
|
Phase 2 |