check_circleStudy Completed

Pharmacology, Clinical

Bayer Identifier:

13469

ClinicalTrials.gov Identifier:

NCT00941057

EudraCT Number:

2009-011963-35

EU CT Number:

Not Available
Bioequivalence study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) without and with levomefolate calcium

Trial purpose

Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium

Key Participants Requirements

Sex

Female

Age

45 - 75 Years
  • - Healthy postmenopausal women, age: 45-75 years with body mass index between ≥18 and ≤30 kg/m2. Post-menopausal state revealed by: medical history, and hormone analyses in serum: estradiol ≤20 pg/mL and in women <60 years old: follicle-stimulating hormone ≥ 40 IU/L at screening
  • - Contraindications for use of combined (Estradiolvalerate/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

Trial summary

Enrollment Goal
43
Trial Dates
September 2009 - January 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
EV/DNG/Folate (BAY98-7079)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Neu-Ulm, 89231, Germany

Primary Outcome

  • AUC
    Area under the concentration vs time curve from zero to infinity for DNG
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
    enhanced_encryption
    Safety Issue:
    no
  • Cmax
    Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast)
    AUC from time 0 to the last data point above the lower limit of quantitation for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • tmax
    Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected)
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
    enhanced_encryption
    Safety Issue:
    No
  • t½
    Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
    enhanced_encryption
    Safety Issue:
    No
  • λz
    Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast)
    AUC from time 0 to the last data point above the lower limit of quantitation for DNG
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
    enhanced_encryption
    Safety Issue:
    No
  • AUC
    Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected)
    date_rangeTime Frame:
    Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open-label, randomized, cross-over study to investigate the bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate calcium after single oral administration of a tablet formulation containing 2 mg Estradiol Valerate and 3 mg Dienogest without and with 0.451 mg Levomefolate calcium and a tablet formulation containing 0.451 mg Levomefolate calcium in 42 healthy postmenopausal women
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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