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.
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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 (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 (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- Are persons who have previously completed or withdrawn from this study or any other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