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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005298-36 | EudraCT Number |
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The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. The investigational substance will be administered in tablet form to healthy women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1128688 [Dose1] | Experimental | BAY1128688 dose level 1 |
|
| BAY1128688 [Dose2] | Experimental | BAY1128688 dose level 2 |
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| BAY1128688 [Dose3] | Experimental | BAY1128688 dose level 3 |
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| BAY1128688 [Dose4] | Experimental | BAY1128688 dose level 4 |
|
| Placebo | Placebo Comparator | Placebo to match arm 1,2, 3 and 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1128688 | Drug | Part A: Single dose and multiple dose for 14 days (postmenopausal women) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading | Up to 2 months | |
| Cmax,md (maximum concentration) of BAY1128688 after multiple dose | 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only) | |
| Cav,md (average steady state concentration) of BAY1128688 after multiple dose | 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only) |
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Inclusion Criteria:
PART A
Postmenopausal state, revealed by
Medical history. One of the following:
Follicle-stimulating hormone (FSH) > 40 IU/L
Age 45 to 68 years
PART B
Healthy female subjects
Completion of more than 3 menstrual cycles after delivery, abortion or lactation
Age 18 to 48 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neu-Ulm | Bavaria | 89231 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37306288 | Derived | Gashaw I, Reif S, Wiesinger H, Kaiser A, Zollmann FS, Scheerans C, Grevel J, Piraino P, Seidel H, Peters M, Rottmann A, Rohde B, Arlt W, Hilpert J. Novel aldo-keto reductase 1C3 inhibitor affects androgen metabolism but not ovarian function in healthy women: a phase 1 study. Eur J Endocrinol. 2023 Jul 10;188(7):578-591. doi: 10.1093/ejendo/lvad063. |
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| Placebo | Drug | Part A: Single dose and multiple dose for 14 days (postmenopausal women) |
|
| BAY1128688 | Drug | Part B: Multiple dose for 28 days (premenopausal women) |
|
| Berlin |
| State of Berlin |
| 13353 |
| Germany |
| Berlin | State of Berlin | 14050 | Germany |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000729512 | BAY1128688 |
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