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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031355
• Other study ID #: 13468
• Secondary ID: 2009-011962-27
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2009
• Last updated: February 18, 2014
• Start date: December 2009
• Est. completion date: March 2010

Study information

• Verified date: February 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Contraception
• Ovulation Inhibition

Intervention

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
• Estradiol Valerate (EV) (BAY86-4980)
Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
• Levomefolate Calcium (BAY86-7660)
Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF		2 months	No

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