Postmenopause
Conditions
Brief summary
The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Postmenopausal women aged 35 to 70 years. * Spontaneous or surgical amenorrhea for at least 6 months. * Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg.
Exclusion criteria
* Hypertension or elevated supine blood pressure (\>139 mm Hg systolic or \>89 mm Hg diastolic). * History of any clinically important drug allergy. * Use of any prescription or investigational drug within 30 days before test article administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE. | — |
Outcome results
None listed