check_circleStudy Completed

Contraception, Ovulation Inhibition

Bayer Identifier:

13468

ClinicalTrials.gov Identifier:

NCT01031355

EudraCT Number:

2009-011962-27

EU CT Number:

Not Available
Bioequivalence study: 3 mg Estradiol Valerate (EV) with and without levomefolate calcium

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

Key Participants Requirements

Sex

Female

Age

45 - 75 Years
  • - BMI:>18 <30 kg/m²
    - Healthy female volunteers
    - Age 45-75 years
    - Postmenopausal state
  • - 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
December 2009 - March 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
EV/DNG/Folate (BAY98-7079)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Nuvisan GmbHNeu-Ulm, 89231, Germany

Primary Outcome

  • Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF
    date_rangeTime Frame:
    2 months
    enhanced_encryption
    Safety Issue:
    no

Trial design

Open-label, randomized, cross-over study to investigate the bioequivalence of estradiol valerate (EV) and levomefolate calcium after single oral administration of a tablet formulation containing 3 mg EV without and with 0.451 mg levomefolate calcium and a tablet formulation containing 0.451 mg levomefolate calcium in 42 healthy postmenopausal women
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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