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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018864-18 | EudraCT Number |
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The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1981 + Oral contraceptive |
|
| 2 | Placebo Comparator | Placebo + Oral contraceptive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1981 | Drug | 4X100 mg per oral, twice daily for 28 days |
| |
| Neovletta 21/28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max. | PK sampling will be performed regularly during the study period of two months. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2 | PD sampling will be done at the end of treatment period 1 and 2. | |
| Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva S Pettersson | AstraZeneca R&D | Study Director |
| Wolfgang Kühn | Quintiles AB, Phase I Services | Principal Investigator |
| Aslak Rautio | Quintiles Hermelinen AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Luleå | Sweden | ||||
| Research Site |
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| ID | Term |
|---|---|
| C569518 | AZD1981 |
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| Drug |
Once daily with (21) or without (28) pause for bleeding. |
|
| Placebo AZD1981 | Drug | 4X100 mg per oral, twice daily for 28 days |
|
| Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study. |
| Steady state PK of 1981 in combo with oral contraceptives AUCτ, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured. | PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2. |
| Uppsala |
| Sweden |