Clinical trial · Interventional
Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670
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
NCT01816815CI-TRIAL-00014298completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY1002670 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- BAY1002670 [0.1mg]
- description
- 0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
- interventionNames
- Drug: BAY1002670
- type
- EXPERIMENTAL
- label
- BAY1002670 [0.5mg]
- description
- 0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
- interventionNames
- Drug: BAY1002670
- type
- EXPERIMENTAL
- label
- BAY1002670 [1.0mg]
- description
- 1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (1)
- DERIVEDSchutt 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. PMID 27288475