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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02262663
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Clinical Trial, Phase I Drug: Vilaprisan (BAY1002670) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : October 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Vilaprisan [0.5mg]
0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
 Drug: Vilaprisan (BAY1002670)
Experimental: Vilaprisan [1mg]
1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
 Drug: Vilaprisan (BAY1002670)
Experimental: Vilaprisan [2mg]
2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
 Drug: Vilaprisan (BAY1002670)
Experimental: Vilaprisan [4mg]
4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
 Drug: Vilaprisan (BAY1002670)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Number of subjects without bleeding/spotting [ Time Frame: After three month treatment ]

Secondary Outcome Measures :
  1. Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling [ Time Frame: After three month treatment ]
  2. Number of subjects with TEAEs (treatment-emergent adverse events) [ Time Frame: After three month treatment and during follow-up (up to 60 days) ]
  3. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262663


Locations
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Germany
Berlin, Germany, 10115
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02262663    
Other Study ID Numbers: 15818
2014-000329-19 ( EudraCT Number )
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016