ContraceptionPhase 1NCT01031355
Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
A Phase 1 study testing Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078), Estradiol Valerate (EV) (BAY86-4980) and Levomefolate Calcium (BAY86-7660) in people with Contraception and Ovulation Inhibition, run by Bayer at 1 site in Germany.
Trial summary
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… 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
- Contraception, Ovulation Inhibition
- What is being tested?
- Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078), Estradiol Valerate (EV) (BAY86-4980) and Levomefolate Calcium (BAY86-7660)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Mar 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
- BMI:>18 <30 kg/m²
- Healthy female volunteers
- Age 45-75 years
- Postmenopausal state
Who cannot join
- 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 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) 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
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
- Conditions
- Contraception, Ovulation Inhibition
- Being tested
- Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078), Estradiol Valerate (EV) (BAY86-4980), Levomefolate Calcium (BAY86-7660)
- Keywords
- Female Contraception, Contraceptives, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)Drug
Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
Estradiol Valerate (EV) (BAY86-4980)Drug
Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days
Levomefolate Calcium (BAY86-7660)Drug
Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) |
| Arm 2 | Active comparator | Not described Receives: Drug: Estradiol Valerate (EV) (BAY86-4980) |
| Arm 3 | Active comparator | Not described Receives: Drug: Levomefolate Calcium (BAY86-7660) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT01031355
- Sponsor's protocol ID
- 13468
- Other IDs
- 2009-011962-27, 2009
- Status last verified
- Feb 2014
- First submitted
- 11 Dec 2009
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. 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) 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
- ClinicalTrials.gov ID
- NCT01031355
- Acronym / sponsor ID
- 13468
- Conditions
- Contraception, Ovulation Inhibition
- Keywords
- Female Contraception, Contraceptives, Oral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Dec 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) 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) |
| Arm 2 | Active comparator | Drug: Estradiol Valerate (EV) (BAY86-4980) |
| Arm 3 | Active comparator | Drug: Levomefolate Calcium (BAY86-7660) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI:>18 <30 kg/m²
- Healthy female volunteers
- Age 45-75 years
- Postmenopausal state
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days | Drug | Arm 1 |
| Estradiol Valerate (EV) (BAY86-4980)Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days | Drug | Arm 2 |
| Levomefolate Calcium (BAY86-7660)Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days | Drug | Arm 3 |
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
Time frame: 2 months
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 20 Feb 2014.
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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 Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078), Estradiol Valerate (EV) (BAY86-4980) and Levomefolate Calcium (BAY86-7660) in people with Contraception and Ovulation Inhibition, 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 4 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 20 Feb 2014. 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?
Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF (time frame: 2 months). 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 20 Feb 2014.