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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01031355

Enrollment

Registered

2009-12-14

Start date

2009-12-31

Completion date

2010-03-31

Last updated

2014-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Ovulation Inhibition

Keywords

Female Contraception, Contraceptives, Oral

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

Interventions

DRUGEstradiol 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

DRUGEstradiol Valerate (EV) (BAY86-4980)

Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days

DRUGLevomefolate Calcium (BAY86-7660)

Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

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

Design outcomes

Primary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026