A Study of Baricitinib and Birth Control Pills in Healthy Females

NCT01896726 | Completed Phase 1 Results

• 2 other identifiers: 14601I4V-MC-JAGD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Drug: Baricitinib; Drug: Microgynon

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

Baricitinib + Microgynon

Microgynon DRUG

Administered orally

Baricitinib + Microgynon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal females currently successfully using non-hormonal methods of contraception including tubular ligation, cervical vault cap, diaphragm, or non-hormonal coil with spermicide will be required in addition to use a second approved method of contraception for the duration of the study \[that is (i.e.), a male sexual partner who agrees to use a male condom with spermicide; a sterile sexual partner; or abstinence (participants reporting abstinence who become sexually active while on the study must agree to use other additional barrier methods of contraception)\]. The pregnancy test result must be negative at screening and at each check-in visit. Participants must have a regular menstrual cycle of approximately 28 days duration for at least 4 previous cycles prior to screening
• Postmenopausal females, or women not of child-bearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, or at least 3 months after bilateral oophorectomy or bilateral tubal occlusion with or without hysterectomy) confirmed by medical history, or menopause. Menopausal women include women with spontaneous amenorrhea for at least 12 months or amenorrhea not induced by a medical condition such as anorexia nervosa and/or not taking medications during that time of amenorrhea \[example (e.g.), oral contraceptives (OCs), hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy\]. Postmenopausal status should be confirmed by a serum follicle-stimulating hormone level at screening greater than 40 international units per liter (IU/L)
• Have a body mass index of 18 to 30 kilograms per square meter (kg/m\^2), inclusive

You may not qualify if:

• Have a positive pregnancy test or are lactating
• Are currently enrolled in, have completed or discontinued within the last 90 days from a clinical trial involving a study drug; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Are persons who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received the study drug
• Have known allergies to baricitinib or Microgynon (containing ethinyl estradiol and levonorgestrel) or related compounds
• Have used or intend to use drugs or substances that are known to be inducers or inhibitors of cytochrome P450 3A (eg, St. John's wort, rifampin, ketoconazole) within 30 days prior to the first dose
• Have taken OCs within 3 months, implanted contraceptives within 6 months, injectable contraceptives within 12 months, or topical controlled delivery contraceptives (patch) or hormonal coils within 3 months prior to the study
• Have a history or presence of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, hormonally-induced migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected)
• Smokes more than 10 cigarettes per day

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, United Kingdom

Location

MeSH Terms

Interventions

baricitinib; ethinyl estradiol, levonorgestrel drug combination

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 6, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Locations

GB (1)