Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
NCT ID: NCT01031355
Last Updated: 2014-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2009-12-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm 1
Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)
Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Arm 2
Estradiol Valerate (EV) (BAY86-4980)
Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
Arm 3
Levomefolate Calcium (BAY86-7660)
Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Interventions
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Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)
Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Estradiol Valerate (EV) (BAY86-4980)
Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
Levomefolate Calcium (BAY86-7660)
Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Eligibility Criteria
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Inclusion Criteria
* Healthy female volunteers
* Age 45-75 years
* Postmenopausal state
Exclusion Criteria
* Regular intake of medication
* Clinically relevant findings (ECG, blood pressure, physical and gynaecological examination, laboratory examination)
* Smoking
45 Years
75 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Neu-Ulm, Bavaria, Germany
Countries
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Other Identifiers
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2009-011962-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13468
Identifier Type: -
Identifier Source: org_study_id
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