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

Study Overview
=================
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

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

Conditions
-----------------
Contraception, Ovulation Inhibition

Intervention / Treatment
-----------------
* Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)
* Drug: Estradiol Valerate (EV) (BAY86-4980)
* Drug: Levomefolate Calcium (BAY86-7660)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)<br>* Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days<br>|
| Active Comparator: Arm 2<br> | Drug: Estradiol Valerate (EV) (BAY86-4980)<br>* Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days<br>|
| Active Comparator: Arm 3<br> | Drug: Levomefolate Calcium (BAY86-7660)<br>* Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female Contraception, Contraceptives, Oral