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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:
Bayer
ClinicalTrials.gov Identifier:
NCT00941057
First received: July 16, 2009
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  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 1

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

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: 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: Arm 1 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: Arm 2 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: Arm 3 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
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

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00941057     History of Changes
Other Study ID Numbers: 13469, 2009-011963-35
Study First Received: July 16, 2009
Last Updated: June 14, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Oral contraception
Female contraception

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

ClinicalTrials.gov processed this record on May 21, 2013