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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to find out how the body absorbs and breaks down a common birth control pill called Microgynon when it is given with the study drug called baricitinib. Safety and the body's ability to tolerate baricitinib and Microgynon will also be studied. The study will last approximately 6 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib + Microgynon | Experimental | Microgynon [30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel] administered orally, once daily (QD), on Days 1 and 29. Baricitinib, 10 milligrams (mg), administered orally QD on Days 23 through 30. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol | Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose | |
| PK: Cmax of Levonorgestrel | Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose | |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol | Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose | |
| PK: AUC(0-∞) of Levonorgestrel | Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leeds | West Yorkshire | LS2 9LH |
This was an open-label, fixed-sequence, 2-period study. Each participant received a single dose of Microgynon on Day 1 of Treatment Period 1. During Treatment Period 2, participants received baricitinib on Days 23 through 30 with coadministration of Microgynon on Day 29.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baricitinib + Microgynon | Microgynon tablet [30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel] administered orally, once daily (QD), on Days 1 and 29. 10 milligrams (mg) baricitinib tablet administered orally, QD, on Days 23 through 30. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Days 1-22) |
| ||||||||||||||||
| Treatment Period 2 (Days 23-31) |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baricitinib + Microgynon | Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Days 1 and 29. 10 mg baricitinib tablet administered orally, QD, on Days 23 through 30. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol | All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate Cmax of ethinyl estradiol. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms/milliliter (pg/mL) | Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose |
|
Baseline through study completion (up to Day 40).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microgynon Alone | Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1. Adverse events are reported from baseline through predose on Day 23. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
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| Microgynon | Drug | Administered orally |
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| United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Primary | PK: Cmax of Levonorgestrel | All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate Cmax of levonorgestrel. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose |
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|
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| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol | All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate AUC(0-∞) of ethinyl estradiol. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms*hour/milliliter (pg*hr/mL) | Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose |
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|
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| Primary | PK: AUC(0-∞) of Levonorgestrel | All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate AUC(0-∞) of levonorgestrel. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*hr/mL | Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose |
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|
|
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | Baricitinib | 10 mg baricitinib tablet administered orally, QD, on Days 23 through 28. Adverse events are reported from postdose on Day 23 through predose on Day 29. | 0 | 20 | 4 | 20 |
| EG002 | Baricitinib + Microgynon | 10 mg baricitinib tablet administered orally, QD, on Days 29 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29. Adverse events are reported from postdose on Day 29 up to Day 40. | 1 | 18 | 4 | 18 |
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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