Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 3 mg EV Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women
2 other identifiers
interventional
42
1 country
1
Brief Summary
Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 11, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFebruary 20, 2014
February 1, 2014
2 months
December 11, 2009
February 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF
2 months
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORArm 3
ACTIVE COMPARATORInterventions
Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Eligibility Criteria
You may qualify if:
- BMI:\>18 \<30 kg/m²
- Healthy female volunteers
- Age 45-75 years
- Postmenopausal state
You may not qualify if:
- Contraindications for use of combined (Estradiol Valerate/dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease)
- Regular intake of medication
- Clinically relevant findings (ECG, blood pressure, physical and gynaecological examination, laboratory examination)
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Neu-Ulm, Bavaria, 89231, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2009
First Posted
December 14, 2009
Study Start
December 1, 2009
Primary Completion
February 1, 2010
Study Completion
March 1, 2010
Last Updated
February 20, 2014
Record last verified: 2014-02