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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01031355

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

42 participants

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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