Clinical Trial, Phase IPhase 1NCT02262663
Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan
A Phase 1 study testing Vilaprisan (BAY1002670) in people with Clinical Trial, Phase I, run by Bayer at 2 sites in Germany.
Trial summary
This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial, Phase I
- What is being tested?
- Vilaprisan (BAY1002670)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2014to Dec 2015
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit
- Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
- Pre-treatment cycle assessed as ovulatory and not longer than 44 days
Who cannot join
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
- Known or suspected liver disorders
- Amenorrhea for more than 3 months within the last 6 months before the first screening examination
- Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
- Positive urine pregnancy test
- Regular use of medicines
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Study site
Berlin, State of Berlin, 10115
Study site
Berlin, State of Berlin, 13353
About this study
Official title: A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety After Daily Oral Administration of 4 Different Doses of Vilaprisan (BAY1002670) in Healthy Women of Reproductive Age
This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.
- Conditions
- Clinical Trial, Phase I
- Being tested
- Vilaprisan (BAY1002670)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilaprisan (BAY1002670)Drug
| Study group | Role | What they receive |
|---|---|---|
| Vilaprisan [0.5mg] | Experimental | 0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days Receives: Drug: Vilaprisan (BAY1002670) |
| Vilaprisan [1mg] | Experimental | 1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days Receives: Drug: Vilaprisan (BAY1002670) |
| Vilaprisan [2mg] | Experimental | 2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days Receives: Drug: Vilaprisan (BAY1002670) |
| Vilaprisan [4mg] | Experimental | 4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days Receives: Drug: Vilaprisan (BAY1002670) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hoogland score during treatment, day 9 to day 28
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Measured: Day 9 to 28
Hoogland score during treatment, day 63 to day 84
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Measured: Day 63 to 84
Hoogland score during follow up cycle 1
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Measured: 4 weeks following treatment period
Hoogland score during follow up cycle 2
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Measured: 4 weeks following follow up cycle 1
Number of subjects without bleeding/spotting
Measured: After three month treatment
Secondary outcomes (3)
Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling
Measured: After three month treatment
Number of subjects with TEAEs (treatment-emergent adverse events)
Measured: After three month treatment and during follow-up (up to 60 days)
Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)
Measured: After three month treatment and during follow-up (up to 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Trial, Phase IStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 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
- NCT02262663
- Sponsor's protocol ID
- 15818
- Other IDs
- 2014-000329-19, 2014
- Status last verified
- Mar 2016
- First submitted
- 9 Oct 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety After Daily Oral Administration of 4 Different Doses of Vilaprisan (BAY1002670) in Healthy Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT02262663
- Acronym / sponsor ID
- 15818
- Conditions
- Clinical Trial, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Oct 2014 (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.
This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vilaprisan [0.5mg] | Experimental | Drug: Vilaprisan (BAY1002670)0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
| Vilaprisan [1mg] | Experimental | Drug: Vilaprisan (BAY1002670)1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
| Vilaprisan [2mg] | Experimental | Drug: Vilaprisan (BAY1002670)2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
| Vilaprisan [4mg] | Experimental | Drug: Vilaprisan (BAY1002670)4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit
- Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
- Pre-treatment cycle assessed as ovulatory and not longer than 44 days
Key exclusion criteria (6 listed)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
- Known or suspected liver disorders
- Amenorrhea for more than 3 months within the last 6 months before the first screening examination
- Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
- Positive urine pregnancy test
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 |
|---|---|---|
| Vilaprisan (BAY1002670) | Drug | Vilaprisan [0.5mg], Vilaprisan [1mg], Vilaprisan [2mg], Vilaprisan [4mg] |
Primary outcome
Hoogland score during treatment, day 9 to day 28
Time frame: Day 9 to 28
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Hoogland score during treatment, day 63 to day 84
Time frame: Day 63 to 84
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Hoogland score during follow up cycle 1
Time frame: 4 weeks following treatment period
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Hoogland score during follow up cycle 2
Time frame: 4 weeks following follow up cycle 1
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Number of subjects without bleeding/spotting
Time frame: After three month treatment
3 secondary outcomes
Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling
Time frame: After three month treatment
Number of subjects with TEAEs (treatment-emergent adverse events)
Time frame: After three month treatment and during follow-up (up to 60 days)
Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)
Time frame: After three month treatment and during follow-up (up to 60 days)
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 16 Mar 2016.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vilaprisan (BAY1002670) in people with Clinical Trial, Phase I, run by Bayer at 2 sites 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 3 inclusion and 6 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hoogland score during treatment, day 9 to day 28 (time frame: Day 9 to 28). The study lists 5 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 16 Mar 2016.