LeiomyomaPhase 1NCT01816815
Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670
A Phase 1 study testing BAY1002670 in people with Leiomyoma, run by Bayer at 6 sites in 3 countries.
Trial summary
Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma
- What is being tested?
- BAY1002670
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Nov 2011to Jan 2013
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects
- Sterilized by tubal ligation
- Age 18-45 years
- Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
- At least 3 consecutive regular menstrual cycles with a cycle length of 24 - 35 days before first screening examination according to the subject's history
- Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
Who cannot join
- Regular use of medicines (incl. anabolics)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Amenorrhea for more than 3 months within the last 6 months before the first screening examination
- Lacking suitability for frequent transvaginal ultrasonography (TVU) examinations
- Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany4 sites
Study site
Berlin, State of Berlin, 10117
Study site
Berlin, State of Berlin, 13353
Study site
Neu-Ulm, Bavaria, 89231
Study site
Neuss, North Rhine-Westphalia, 41450
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in 60 Healthy Tubal-ligated Women Aged 18 to 45 Years Investigating the Pharmacodynamic Effects of 5 Different Doses (0.1 - 5 mg) BAY1002670 After Daily Oral Administration Over 84 Days
Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship
- Conditions
- Leiomyoma
- Being tested
- BAY1002670, Placebo
- Keywords
- PK/PD, BAY1002670
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1002670Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BAY1002670 [0.1mg] | Experimental | 0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days Receives: Drug: BAY1002670 |
| BAY1002670 [0.5mg] | Experimental | 0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days Receives: Drug: BAY1002670 |
| BAY1002670 [1.0mg] | Experimental | 1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days Receives: Drug: BAY1002670 |
| BAY1002670 [2.0mg] | Experimental | 2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days Receives: Drug: BAY1002670 |
| BAY1002670 [5.0mg] | Experimental | 5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days Receives: Drug: BAY1002670 |
| Placebo | Placebo comparator | Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)
Measured: After three months
Secondary outcomes (1)
Return of menstrual bleeding after treatment
Measured: Up to two months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies 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
- 73 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
- NCT01816815
- Sponsor's protocol ID
- 14723
- Other IDs
- 2011-001760-22
- Status last verified
- Apr 2014
- First submitted
- 20 Mar 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schutt B, Kaiser A, Schultze-Mosgau MH, Seitz C, Bell D, Koch M, Rohde B. Pharmacodynamics and safety of the novel selective progesterone receptor modulator vilaprisan: a double-blind, randomized, placebo-controlled phase 1 trial in healthy women. Hum Reprod. 2016 Aug;31(8):1703-12. doi: 10.1093/humrep/dew140. Epub 2016 Jun 10.
PubMed 27288475
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in 60 Healthy Tubal-ligated Women Aged 18 to 45 Years Investigating the Pharmacodynamic Effects of 5 Different Doses (0.1 - 5 mg) BAY1002670 After Daily Oral Administration Over 84 Days
- ClinicalTrials.gov ID
- NCT01816815
- Acronym / sponsor ID
- 14723
- Conditions
- Leiomyoma
- Keywords
- PK/PD, BAY1002670
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Mar 2013 (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.
Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BAY1002670 [0.1mg] | Experimental | Drug: BAY10026700.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| BAY1002670 [0.5mg] | Experimental | Drug: BAY10026700.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| BAY1002670 [1.0mg] | Experimental | Drug: BAY10026701.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| BAY1002670 [2.0mg] | Experimental | Drug: BAY10026702.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| BAY1002670 [5.0mg] | Experimental | Drug: BAY10026705.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy female subjects
- Sterilized by tubal ligation
- Age 18-45 years
- Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
- At least 3 consecutive regular menstrual cycles with a cycle length of 24 - 35 days before first screening examination according to the subject's history
Key exclusion criteria (5 listed)
- Regular use of medicines (incl. anabolics)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Amenorrhea for more than 3 months within the last 6 months before the first screening examination
- Lacking suitability for frequent transvaginal ultrasonography (TVU) examinations
- Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
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 |
|---|---|---|
| BAY1002670 | Drug | BAY1002670 [0.1mg], BAY1002670 [0.5mg], BAY1002670 [1.0mg], BAY1002670 [2.0mg], BAY1002670 [5.0mg] |
| Placebo | Drug | Placebo |
Primary outcome
Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)
Time frame: After three months
1 secondary outcome
Return of menstrual bleeding after treatment
Time frame: Up to two months after last treatment
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 21 Apr 2014.
- Derived from this study: PubMed 27288475Schutt B, Kaiser A, Schultze-Mosgau MH, Seitz C, Bell D, Koch M, Rohde B. Pharmacodynamics and safety of the novel selective progesterone receptor modulator vilaprisan: a double-blind, randomized, placebo-controlled phase 1 trial in healthy women. Hum Reprod. 2016 Aug;31(8):1703-12. doi: 10.1093/humrep/dew140. Epub 2016 Jun 10.
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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
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1002670 in people with Leiomyoma, run by Bayer at 6 sites in 3 countries.
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 6 inclusion and 5 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Belgium, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment) (time frame: After three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816815, which also lists 1 linked publication.
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 21 Apr 2014.