Status:
COMPLETED
Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium
Lead Sponsor:
Bayer
Conditions:
Pharmacology, Clinical
Eligibility:
FEMALE
45-75 years
Phase:
PHASE1
Brief Summary
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 L...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00941057
Start Date
September 1 2009
End Date
January 1 2010
Last Update
August 1 2016
Active Locations (1)
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1
Neu-Ulm, Bavaria, Germany, 89231