Clinical trial NCT00941057: Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium
Official title: Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV), Dienogest (DNG) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 2 mg Estradiol Valerate and 3 mg Dienogest Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacology, Clinical
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 43
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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 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


Eligibility criteria: 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

Primary outcomes:
measure: AUC
timeFrame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
measure: Cmax
timeFrame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
measure: AUC(0-tlast)
timeFrame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
Secondary outcomes:
measure: tmax
timeFrame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
measure: t½
timeFrame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
measure: λz
timeFrame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
measure: AUC(0-tlast)
timeFrame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
measure: AUC
timeFrame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
state: Bayern
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: