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Completed

NCT Number: NCT00941057

Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium

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

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Key information

Conditions

Pharmacology, Clinical

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Neu-Ulm, Bavaria, 89231, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium

Drug

Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)

Drug

Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days

BAY 86-7660,levomefolate calcium

Drug

Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

Primary outcomes

  1. AUC

    Time 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

    Area under the concentration vs time curve from zero to infinity for DNG

  2. Cmax

    Time 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

    Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)

  3. AUC(0-tlast)

    Time 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

    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)

Secondary outcomes

  1. tmax

    Time 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

    Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected)

  2. t½

    Time 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

    Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF

  3. λz

    Time 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

    Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF

  4. AUC(0-tlast)

    Time 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

    AUC from time 0 to the last data point above the lower limit of quantitation for DNG

  5. AUC

    Time 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

    Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 17, 2009
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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