NCT00941057

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

July 16, 2009

Last Update Submit

July 29, 2016

Conditions

Pharmacology, Clinical

Outcome Measures

Primary Outcomes (3)

  • AUC

    Area under the concentration vs time curve from zero to infinity for DNG

    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

  • Cmax

    Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)

    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

  • AUC(0-tlast)

    AUC from time 0 to the last data point above the lower limit of quantitation for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)

    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 (5)

  • tmax

    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

  • t½

    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

  • λz

    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

  • AUC(0-tlast)

    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

  • AUC

    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

Study Arms (3)

Estradiol + dienogest + levomefolate

EXPERIMENTAL

Treatment A

Drug: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium

Estradiol + dienogest

ACTIVE COMPARATOR

Treatment B

Drug: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)

Levomefolate

ACTIVE COMPARATOR

Treatment C

Drug: BAY 86-7660,levomefolate calcium

Interventions

BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calciumDRUG

Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

Estradiol + dienogest + levomefolate
BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)DRUG

Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days

Estradiol + dienogest
BAY 86-7660,levomefolate calciumDRUG

Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days

Levomefolate

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neu-Ulm, Bavaria, 89231, Germany

Location

Related Links

MeSH Terms

Interventions

dienogestlevomefolate calcium

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2009

First Posted

July 17, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

DE(1)