A Phase 1 interventional study of Vilaprisan (BAY1002670) in Uterine Fibroids and Endometriosis, sponsored by Bayer. Completed at 2 sites in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by Bayer · Phase 1, Interventional, and Other
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Among 12 studies testing vilaprisan in Leiomyoma — none open to participants now, none under way, none of them phase 3. vilaprisan · Leiomyoma.
Among the 12 studies testing vilaprisan in Leiomyoma, this one is the 10th largest by enrollment, is one of 5 that started in 2018, is one of 4 in phase 1, and was the 10th registered.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
Browse Leiomyoma studies →None of the 12 studies testing vilaprisan in Leiomyoma is open now. The open studies under Leiomyoma, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 43 Leiomyoma studies recruiting now, 21 (49%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 79 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 5 started in 2018.
This study's enrollment of 26 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.
Median enrollment 98 across the 12 interventional studies. Of the 11 that completed or were terminated, 4 (36%) have results posted.
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12 of 12 have an industry lead sponsor. The 1 most frequent:
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
12 studies in Leiomyoma by Bayer: none open now, none under way, none of them phase 3. Of 11 finished, 4 (36%) have results posted.
Among the 12 studies in Leiomyoma by Bayer, this one is the 10th largest by enrollment, is one of 5 that started in 2018, is one of 4 in phase 1, and was the 10th registered.
Bayer’s Leiomyoma studies by the year they started, since 2011.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing vilaprisan in Leiomyoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Bayer’s 12 in Leiomyoma:
Nothing recorded among them since 2026-09-25.
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The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.
This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR \<30 mL/min/1.73 m*2 but not on dialysis
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m\*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Drug: Vilaprisan (BAY1002670)
Subjects with severe renal impairment not on dialysis with an eGFR \<30 mL/min/1.73 m\*2 (CKD-EPI formula).
Drug: Vilaprisan (BAY1002670)
Subjects with an eGFR ≥90 mL/min/1.73 m\*2 (CKD-EPI formula) who are matched based on sex, age, race and weight.
Drug: Vilaprisan (BAY1002670)
Single oral dose (1 x 2 mg immediate-release, film-coated tablet)
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670
Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation \[AUC(0-tlast)\], if AUC cannot be estimated in all subjects. In subjects with normal and moderately reduced renal function.
Time frame: -1hour (h), 30minutes (min), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1day (d), 2d, 3d, 4d, 7d, 10d, 14d
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670
In subjects with normal and moderately reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Number of participants with adverse events
In subjects with normal, moderately, and severely reduced renal function.
Time frame: Up to 6 weeks
AUC
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
unbound AUC (AUCu)
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Cmax
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Unbound Cmax (Cmax,u)
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Apparent oral clearance (CL/F)
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Unbound CL/F (CLu/F)
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Half-life associated with the terminal slope (t1/2)
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Renal clearance (CLR)
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Fraction of free (unbound) drug in plasma (fu)
In subjects with normal, moderately, and severely reduced renal function.
Time frame: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Ran from Feb 2018 to primary completion in Oct 2018, 8 months.
Of 13 phase 1 interventional studies under Leiomyoma, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 41. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vilaprisan