Trial Condition(s):

Pharmacology, clinical

Bioequivalence study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) without and with levomefolate calcium

Bayer Identifier:

13469

ClinicalTrials.gov Identifier:

NCT00941057

EudraCT Number:

2009-011963-35

Study Completed

Trial Purpose

Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium

Inclusion Criteria
- Healthy postmenopausal women, age: 45-75 years with body mass index between ≥18 and ≤30 kg/m2. Post-menopausal state revealed by: medical history, and hormone analyses in serum: estradiol ≤20 pg/mL and in women <60 years old: follicle-stimulating hormone  ≥ 40 IU/L at screening
Exclusion Criteria
- Contraindications for use of combined (Estradiolvalerate/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
43
Trial Dates
black-arrow
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

Investigative Site

Neu-Ulm, Germany, 89231

Status
Completed
 

Trial Design