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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00941057
First received: July 16, 2009
Last updated: July 29, 2016
Last verified: July 2016
  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

Condition Intervention Phase
Pharmacology, Clinical
Drug: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium
Drug: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)
Drug: BAY 86-7660,levomefolate calcium
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Area under the concentration vs time curve from zero to infinity for DNG

  • 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 ] [ Designated as safety issue: No ]
    Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected)

  • 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 ] [ Designated as safety issue: No ]
    Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF

  • 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 ] [ Designated as safety issue: No ]
    Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF

  • 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 ] [ Designated as safety issue: No ]
    AUC from time 0 to the last data point above the lower limit of quantitation for DNG

  • 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 ] [ Designated as safety issue: No ]
    Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected)


Enrollment: 43
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol + dienogest + levomefolate
Treatment A
Drug: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium
Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
Active Comparator: Estradiol + dienogest
Treatment B
Drug: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)
Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days
Active Comparator: Levomefolate
Treatment C
Drug: BAY 86-7660,levomefolate calcium
Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941057

Locations
Germany
Neu-Ulm, Bayern, Germany, 89231
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00941057     History of Changes
Other Study ID Numbers: 13469  2009-011963-35 
Study First Received: July 16, 2009
Last Updated: July 29, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Calcium, Dietary
Estradiol
Polyestradiol phosphate
Nandrolone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Dienogest
Bone Density Conservation Agents
Physiological Effects of Drugs
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Anabolic Agents

ClinicalTrials.gov processed this record on September 30, 2016