We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01031355
First Posted: December 14, 2009
Last Update Posted: February 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg Estradiol Valerate 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 Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) Drug: Estradiol Valerate (EV) (BAY86-4980) Drug: Levomefolate Calcium (BAY86-7660) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 3 mg EV 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:
  • 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 ]

Enrollment: 42
Study Start Date: December 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)
Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Active Comparator: Arm 2 Drug: Estradiol Valerate (EV) (BAY86-4980)
Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
Active Comparator: Arm 3 Drug: Levomefolate Calcium (BAY86-7660)
Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications for use of combined (Estradiol Valerate/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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031355


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: NCT01031355     History of Changes
Other Study ID Numbers: 13468
2009-011962-27 ( EudraCT Number )
First Submitted: December 11, 2009
First Posted: December 14, 2009
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Bayer:
Female Contraception
Contraceptives, Oral

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