A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities

- Be a woman 18 to 45 years of age, inclusive .
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Willing to adhere to the prohibitions and restrictions specified in this protocol (Section 4.4, Prohibitions and Restrictions).
- Must be either: 1. surgically sterile or 2. of child-bearing potential and be practicing an effective non-hormonal method of birth control (e.g., copper intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study. Women, who are not heterosexually active at Screening, must agree to utilize a highly-effective non-hormonal method of birth control if they become heterosexually active during their participation in the study.
- If a woman of child-bearing potential, must have a negative serum β-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 of the each treatment period.
- Must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the last dose.
- Body mass index (BMI; weight [kg]/height2 [m]2) between 18.5 and 30 kg/m2 (inclusive), and body weight not less than 50 kg or higher than 90 kg (198 pounds).
- Blood pressure (after the subject is sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
- A 12-lead ECG consistent with normal cardiac conduction and function.
- Non-smoker.

- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic impairment, renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
- Contraindications to combined hormonal contraceptives.
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as deemed appropriate by the investigator
- Hematocrit less than 36%
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening or at admission to the study center as deemed appropriate by the investigator
- Abnormal Papanicolaou (Pap) smear or CytoRich test
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, within 14 days before the first dose of the study drug is scheduled
- Has a levonorgestrel implant (e.g., Norplant®) in place or removed within the 60 days before admission to the study site,
- Received medroxyprogesterone injection (e.g., Depo Provera®) within 6 months of admission to the study
- Use of any other hormonal contraceptive within 60 days of Day -1 of Period 1
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at Screening and Day -1 of the each treatment period
- Known allergy to the study drug or any of the excipients of the formulation
- Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
- Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug*s half-life, whichever is longer, before the first dose of the study drug is scheduled
- Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
- Pregnant, breast-feeding or planning to become pregnant during the study
- Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
- History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or subject*s verbal report, or positive urine cotinine test at screening and on Day -1 of the each treatment period
- Preplanned surgery or procedures that would interfere with the conduct of the study
- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.