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

NCT01031355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-02-20

No results posted yet for this study

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

Conditions

  • Contraception
  • Ovulation Inhibition

Interventions

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

DRUG

Estradiol Valerate (EV) (BAY86-4980)

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

DRUG

Levomefolate Calcium (BAY86-7660)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-02-28
Completion
2010-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01031355 on ClinicalTrials.gov