Pharmacology, ClinicalPhase 1NCT00941057
Bioequivalence Study: 2 mg Estradiol Valerate (EV) and 3 mg Dienogest (DNG) Without and With Levomefolate Calcium
A Phase 1 study testing BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium, BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG) and BAY 86-7660,levomefolate calcium in people with Pharmacology, Clinical, run by Bayer at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacology, Clinical
- What is being tested?
- BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium, BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG) and BAY 86-7660,levomefolate calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Pharmacology, Clinical
- Being tested
- BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium, BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG), BAY 86-7660,levomefolate calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
BAY 86-7660,levomefolate calciumDrug
Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
| Study group | Role | What they receive |
|---|---|---|
| Estradiol + dienogest + levomefolate | Experimental | Treatment A Receives: Drug: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium |
| Estradiol + dienogest | Active comparator | Treatment B Receives: Drug: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG) |
| Levomefolate | Active comparator | Treatment C Receives: Drug: BAY 86-7660,levomefolate calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the concentration vs time curve from zero to infinity for DNG
Measured: 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)
Measured: 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)
Measured: 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
Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected)
Measured: 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
Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF
Measured: 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
Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF
Measured: 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 DNG
Measured: 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
Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacology, ClinicalStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941057
- Sponsor's protocol ID
- 13469
- Other IDs
- 2009-011963-35, 2009
- Status last verified
- Jul 2016
- First submitted
- 16 Jul 2009
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00941057
- Acronym / sponsor ID
- 13469
- Conditions
- Pharmacology, Clinical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Estradiol + dienogest + levomefolate | Experimental | Drug: BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calciumTreatment A |
| Estradiol + dienogest | Active comparator | Drug: BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)Treatment B |
| Levomefolate | Active comparator | Drug: BAY 86-7660,levomefolate calciumTreatment C |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calciumOral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days | Drug | Estradiol + dienogest + levomefolate |
| BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG)Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days | Drug | Estradiol + dienogest |
| BAY 86-7660,levomefolate calciumOral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days | Drug | Levomefolate |
Primary outcome
AUC
Time frame: 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
Area under the concentration vs time curve from zero to infinity for DNG
Cmax
Time frame: 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
Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
AUC(0-tlast)
Time frame: 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 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)
5 secondary outcomes
tmax
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY 98-7079, Estradiolvalerate (EV) / Dienogest (DNG) / Levomefolate calcium, BAY 86-5027,Estradiolvalerate(EV) / Dienogest (DNG) and BAY 86-7660,levomefolate calcium in people with Pharmacology, Clinical, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.