Menopause Clinical Trial
Official title:
Phase 1, Open-Label, Randomized, Single-Dose, Crossover Bioequivalence And Food Effect Study For A New Formulation Of Premarin Compared With A Reference Tablet In Japanese Healthy Postmenopausal Women
Verified date | March 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
Status | Completed |
Enrollment | 72 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Japanese healthy postmenopausal women Exclusion Criteria: - History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies. - History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malignancy, except for basal or squamous cell carcinoma of skin, which has been treated and fully resolved for a minimal 5 years. - History or presence of benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Japan | Pfizer Investigational Site | Shinjyuku-ku | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax | Day 1 to Day 4 | No | |
Primary | Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall | Day 1 to Day 4 | No | |
Primary | Plasma unconjugated equilin pharmacokinetic parameter:Cmax | Day 1 to Day 4 | No | |
Primary | Plasma unconjugated equilin pharmacokinetic parameter:AUCall | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated equilin pharmacokinetic parameter:Tmax | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated equilin pharmacokinetic parameter:AUClast | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated equilin pharmacokinetic parameter:AUCinf | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated equilin pharmacokinetic parameter:MRT | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated equilin pharmacokinetic parameter:half-life | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall | Day 1 to Day 4 | No | |
Secondary | Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT | Day 1 to Day 4 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04553029 -
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
|
||
Completed |
NCT03672513 -
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
|
N/A | |
Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04210583 -
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
Completed |
NCT05617287 -
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
|
N/A | |
Recruiting |
NCT05180266 -
Therapeutic Touch and Music in The Menopausal Period
|
N/A | |
Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
Completed |
NCT03363997 -
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
|
Phase 1 | |
Not yet recruiting |
NCT04728126 -
Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
|
||
Not yet recruiting |
NCT04724135 -
Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
|
||
Completed |
NCT02274571 -
Raising Insulin Sensitivity in Post Menopause
|
Early Phase 1 | |
Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
Recruiting |
NCT01488903 -
A Cohort Research of Genetic Susceptibility for Common Obesity in Women
|
N/A | |
Terminated |
NCT01633814 -
Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women
|
N/A | |
Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A |