MedDataX Logo

Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan

NCT ID: NCT02262663

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)

NCT03092999

Leiomyoma
COMPLETED PHASE1

First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784

NCT02212080

Clinical Trials, Phase I as Topic
COMPLETED PHASE1

A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479

NCT05440799

Healthy
COMPLETED PHASE1

Study in Postmenopausal Women to Investigate the Drug-drug Interaction (DDI) Between Itraconazole(ITZ) and Orally Administered Vilaprisan; Absolute Bioavailability Using Intravenous Microtracer Dose of [14C]Vilaprisan

NCT02456129

Clinical Trial, Phase I
COMPLETED PHASE1

BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

NCT03427788

Endometriosis
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinical Trial, Phase I

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vilaprisan [0.5mg]

0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Group Type EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type DRUG

Vilaprisan [1mg]

1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Group Type EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type DRUG

Vilaprisan [2mg]

2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Group Type EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type DRUG

Vilaprisan [4mg]

4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Group Type EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vilaprisan (BAY1002670)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Berlin, State of Berlin, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-000329-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15818

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
NCT01763333 COMPLETED PHASE1
A Study in Healthy People to Test How 2 Different Doses of BI 1291583 Are Taken up in the Body When Given in 3 Different Formulations
NCT06631417 COMPLETED PHASE1
Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.
NCT02183662 COMPLETED PHASE1
Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)
NCT00918476 COMPLETED PHASE1
Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
NCT01053520 COMPLETED PHASE1
Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers
NCT02265653 COMPLETED PHASE1
Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF)Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose)in Healthy Female Subjects
NCT02438696 COMPLETED PHASE1
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants
NCT03796260 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667
NCT02133482 WITHDRAWN PHASE1
Metabolism and Pharmacokinetics of [14C]-BIIL 284 BS in Healthy Volunteers
NCT02266550 COMPLETED PHASE1
Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
NCT01215773 COMPLETED PHASE1
The Effect of Multiple Oral Doses of BI 1356 BS on Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of Simvastatin and on the Pharmacokinetics of Its Metabolite Simvastatin Acid in Healthy Male Volunteers
NCT02183623 COMPLETED PHASE1
Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
NCT03119077 TERMINATED PHASE1
Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers
NCT02173652 COMPLETED PHASE1
Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers
NCT02183610 COMPLETED PHASE1
A Study to Test How Well Multiple Doses of BI 3810477 Are Tolerated by Healthy Adults
NCT06984926 ACTIVE_NOT_RECRUITING PHASE1
A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference Between Oral Dose and Dose in the Vein
NCT03773068 COMPLETED PHASE1
Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810
NCT02722018 COMPLETED PHASE1
Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers
NCT02268604 TERMINATED PHASE1
Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.
NCT04027192 COMPLETED PHASE1
A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood
NCT06647810 COMPLETED PHASE1
Relative Bioavailability and Tolerability of Various Experimental Formulations of BIBV 308 SE in Healthy Subjects
NCT02223000 COMPLETED PHASE1
Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006
NCT00119639 COMPLETED PHASE1
Study of BB-025, Alone and After BB-031, in Healthy Volunteers
NCT07202663 RECRUITING PHASE1