Trial Condition(s):
Postmenopause, Pharmacokinetics
Study to evaluate the effect of Dienogest on Estradiol Valerate pharmacokinetics in postmenopausal women
Bayer Identifier:
91032
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
Please see attached Study Results Summary below.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
24
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Estradiol Valerate/Dienogest (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
N/A
Where to Participate
Locations
| Locations |
|---|
Trial Design
Open-label, randomized, two-way crossover study to assess the effect of dienogest on estradiol valerate pharmacokinetics after single oral administration of two different microcrystalline suspensions containing 4 mg estradiol valerate or 4 mg estradiol valerate + 4 mg dienogest in 24 healthy postmenopausal volunteers
Trial Type:
Interventional
Intervention Type:
N/A
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
N/A
Primary Outcome
- Timeframe:
Secondary Outcome
- Timeframe:
Additional Information
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