Multi-center, randomized, comparator-controlled, single-blind, parallel-group study to investigate the pharmacodynamics, pharmacokinetics and safety of an intrauterine system releasing BAY 1007626, as compared with Mirena and Jaydess, in a combined proof-of-concept and dose-finding study in healthy pre-menopausal women treated for 90 days
Phase 2
Completed
- Conditions
- contraceptionfertility control
- Registration Number
- NL-OMON42633
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
Inclusion Criteria
Healthy female subjects
Exclusion Criteria
Criteria which in the opinion of the investigator preclude participation for scientific reasons or because of the subject*s safety.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to investigate local and systemic<br /><br>effects of BAY 1007626 on:<br /><br>- Number of bleeding and spotting days,<br /><br>- Endometrial histology,<br /><br>- Ovulation (as surrogate for systemic effects).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of this study is to assess the effects of BAY 1007626<br /><br>on:<br /><br>- Endometrial thickness,<br /><br>- Bleeding characterization (intensity and pattern),<br /><br>- Serum levels of hormones (estradiol, progesterone,luteinizing hormone,<br /><br>follicle-stimulating hormone),<br /><br>- Cervix function (Insler score),<br /><br>- Safety and tolerability (treatment emergent adverse events and SAE),<br /><br>- Pharmacokinetics (PK) following intrauterine application of BAY 1007626.</p><br>