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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00941057

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
Contraception Ovulation Inhibition Contraceptives, Oral	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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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:

MedlinePlus related topics: Birth Control Calcium

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Dienogest Estradiol dipropionate Calcium gluconate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Cmax and AUC (if possible) of DNG as well as uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	October 2009
Study Completion Date:	January 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	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
Arm 2: Active Comparator	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
Arm 3: Active Comparator	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
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Signed Informed Consent
BMI:>18 <30 kg/m²
Healthy female volunteers
Age 45-75 years
Postmenopausal state

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

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

Locations

Germany, Bayern

Neu-Ulm, Bayern, Germany, 89231

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Head Clinical Pharmacology )
Study ID Numbers:	13469, EudraCT:2009-011963-35
Study First Received:	July 16, 2009
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00941057 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Bayer:

Oral contraception
Female contraception

Additional relevant MeSH terms:

Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents

Estradiol 17 beta-cypionate
Reproductive Control Agents
Contraceptive Agents, Male
Hormones
Estradiol
Pharmacologic Actions
Calcium, Dietary
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate
Dienogest

ClinicalTrials.gov processed this record on February 08, 2010