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Trial record 29 of 62 for:    Baricitinib

A Study of Baricitinib and Birth Control Pills in Healthy Females

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ClinicalTrials.gov Identifier: NCT01896726
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Baricitinib
Drug: Microgynon
Enrollment 20
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Baricitinib + Microgynon
Hide Arm/Group Description 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.
Period Title: Treatment Period 1 (Days 1-22)
Started 20
Received Microgynon 20
Completed 20
Not Completed 0
Period Title: Treatment Period 2 (Days 23-31)
Started 20
Received at Least 1 Dose of Baricitinib 20
Received Microgynon 18
Completed 18
Not Completed 2
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
Arm/Group Title Baricitinib + Microgynon
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
44.1  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
20
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  15.0%
White
17
  85.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 20 participants
20
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microgynon Alone Baricitinib + Microgynon
Hide Arm/Group Description:
Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
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.
Overall Number of Participants Analyzed 20 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picograms/milliliter (pg/mL)
63.8
(23%)
59.7
(24%)
2.Primary Outcome
Title PK: Cmax of Levonorgestrel
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microgynon Alone Baricitinib + Microgynon
Hide Arm/Group Description:
Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
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.
Overall Number of Participants Analyzed 20 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
3390
(34%)
3340
(26%)
3.Primary Outcome
Title PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microgynon Alone Baricitinib + Microgynon
Hide Arm/Group Description:
Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
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.
Overall Number of Participants Analyzed 20 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picograms*hour/milliliter (pg*hr/mL)
694
(24%)
697
(25%)
4.Primary Outcome
Title PK: AUC(0-∞) of Levonorgestrel
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microgynon Alone Baricitinib + Microgynon
Hide Arm/Group Description:
Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
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.
Overall Number of Participants Analyzed 20 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg*hr/mL
48200
(58%)
42400
(45%)
Time Frame Baseline through study completion (up to Day 40).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Microgynon Alone Baricitinib Baricitinib + Microgynon
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Microgynon Alone Baricitinib Baricitinib + Microgynon
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Microgynon Alone Baricitinib Baricitinib + Microgynon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      1/18 (5.56%)    
Injury, poisoning and procedural complications       
Maternal exposure during pregnancy  1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Microgynon Alone Baricitinib Baricitinib + Microgynon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/20 (15.00%)      4/20 (20.00%)      4/18 (22.22%)    
Gastrointestinal disorders       
Diarrhoea  1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Flatulence  1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations       
Vulvovaginal candidiasis  1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Metabolism and nutrition disorders       
Decreased appetite  1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  1/20 (5.00%)  1 2/20 (10.00%)  2 0/18 (0.00%)  0
Nervous system disorders       
Headache  1  2/20 (10.00%)  2 1/20 (5.00%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01896726     History of Changes
Other Study ID Numbers: 14601
I4V-MC-JAGD ( Other Identifier: Eli Lilly and Company )
First Submitted: July 8, 2013
First Posted: July 11, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017