Trial Condition(s):

Contraception, Ovulation inhibition

Bioequivalence study: 3 mg Estradiol Valerate (EV) with and without levomefolate calcium

Bayer Identifier:

13468

ClinicalTrials.gov Identifier:

NCT01031355

EudraCT Number:

2009-011962-27

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
42
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
EV/DNG/Folate (BAY98-7079)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Nuvisan GmbH

Neu-Ulm, Germany, 89231

Status
Completed
 

Trial Design