Trial Outcomes & Findings for A Study of Baricitinib and Birth Control Pills in Healthy Females (NCT NCT01896726)
NCT ID: NCT01896726
Last Updated: 2017-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
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
Results posted on
2017-06-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Treatment Period 1 (Days 1-22)
STARTED
|
20
|
|
Treatment Period 1 (Days 1-22)
Received Microgynon
|
20
|
|
Treatment Period 1 (Days 1-22)
COMPLETED
|
20
|
|
Treatment Period 1 (Days 1-22)
NOT COMPLETED
|
0
|
|
Treatment Period 2 (Days 23-31)
STARTED
|
20
|
|
Treatment Period 2 (Days 23-31)
Received at Least 1 Dose of Baricitinib
|
20
|
|
Treatment Period 2 (Days 23-31)
Received Microgynon
|
18
|
|
Treatment Period 2 (Days 23-31)
COMPLETED
|
18
|
|
Treatment Period 2 (Days 23-31)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Treatment Period 2 (Days 23-31)
Adverse Event
|
1
|
|
Treatment Period 2 (Days 23-31)
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study of Baricitinib and Birth Control Pills in Healthy Females
Baseline characteristics by cohort
| Measure |
Baricitinib + Microgynon
n=20 Participants
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.
|
|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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.
Outcome measures
| Measure |
Microgynon Alone
n=20 Participants
Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
|
Baricitinib + Microgynon
n=18 Participants
10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol
|
63.8 picograms/milliliter (pg/mL)
Geometric Coefficient of Variation 23
|
59.7 picograms/milliliter (pg/mL)
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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.
Outcome measures
| Measure |
Microgynon Alone
n=20 Participants
Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
|
Baricitinib + Microgynon
n=18 Participants
10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
|
|---|---|---|
|
PK: Cmax of Levonorgestrel
|
3390 pg/mL
Geometric Coefficient of Variation 34
|
3340 pg/mL
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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.
Outcome measures
| Measure |
Microgynon Alone
n=20 Participants
Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
|
Baricitinib + Microgynon
n=18 Participants
10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol
|
694 picograms*hour/milliliter (pg*hr/mL)
Geometric Coefficient of Variation 24
|
697 picograms*hour/milliliter (pg*hr/mL)
Geometric Coefficient of Variation 25
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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.
Outcome measures
| Measure |
Microgynon Alone
n=20 Participants
Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
|
Baricitinib + Microgynon
n=18 Participants
10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
|
|---|---|---|
|
PK: AUC(0-∞) of Levonorgestrel
|
48200 pg*hr/mL
Geometric Coefficient of Variation 58
|
42400 pg*hr/mL
Geometric Coefficient of Variation 45
|
Adverse Events
Microgynon Alone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Baricitinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Baricitinib + Microgynon
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Microgynon Alone
n=20 participants at risk
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.
|
Baricitinib
n=20 participants at risk
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.
|
Baricitinib + Microgynon
n=18 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 40).
|
Other adverse events
| Measure |
Microgynon Alone
n=20 participants at risk
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.
|
Baricitinib
n=20 participants at risk
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.
|
Baricitinib + Microgynon
n=18 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 40).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 40).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 40).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • Baseline through study completion (up to Day 40).
|
5.0%
1/20 • Number of events 1 • Baseline through study completion (up to Day 40).
|
5.6%
1/18 • Number of events 1 • Baseline through study completion (up to Day 40).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Baseline through study completion (up to Day 40).
|
10.0%
2/20 • Number of events 2 • Baseline through study completion (up to Day 40).
|
0.00%
0/18 • Baseline through study completion (up to Day 40).
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • Baseline through study completion (up to Day 40).
|
5.0%
1/20 • Number of events 1 • Baseline through study completion (up to Day 40).
|
0.00%
0/18 • Baseline through study completion (up to Day 40).
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60