A Study of Baricitinib and Birth Control Pills in Healthy Females
Condition: Healthy Volunteers
Intervention: Baricitinib; Microgynon
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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