Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
The purpose of this study in healthy sexually active females is to evaluate the cycle control
 with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.
This is a randomized, open-label, active-controlled, multicenter study in healthy sexually
 active females to evaluate cycle control with norgestimate/ethinyl estradiol versus
 drospireneone/ethinyl estradiol. The Open-Label Treatment Phase will last for three 28-day
 cycles. Approximately 300 patients will be randomized in a 1:1 fashion according to a
 predetermined randomization schedule. Patients will be seen for a baseline visit (Visit 1) up
 to 35 days prior to dosing to obtain informed consent, have a physical examination including
 a breast exam, height and weight, vital signs, a Chlamydia test and a urine pregnancy test
 performed, and to give their medical history. Patients will be instructed to report bleeding
 data using an interactive voice response system (IVRS) based diary on a daily basis. Patients
 will be instructed to continue taking 1 pill each day for 3 cycles, record this information
 daily in the IVRS and to contact the study site if they have any questions or adverse events
 they would like to discuss. The final study visit (Visit 2) will occur on Day 8 after
 completing 3 cycles of study medication. Patients will be weighed, have vital signs
 performed, report any adverse events and or changes in concomitant medications, and complete
 the satisfaction questionnaire at the final visit. Safety will be assessed by physical
 examinations, adverse events, body weight and vital signs. Patients randomized to
 drospireneone/ethinyl estradiol and taking any medication that could increase serum potassium
 levels (as outlined in the Package Insert) will also have their potassium level checked
 during their first cycle of treatment (Days 15 to 28 of treatment). Three 28-day cycles of
 either norgestimate/ethinyl estradiol or drospirenone/ethinyl estradiol.
Inclusion Criteria:

 -  Healthy females who want oral contraception

 -  No cervical or vaginal abnormalities on gynecological examination

 -  Negative Chlamydia test

 -  Pap smear without evidence of moderate or severe dysplasia or any malignancy within
 the preceding 12 months

 -  Negative urine pregnancy test conducted during Visit 1

 -  One normal menstrual period in 35 days prior to Visit 1

 -  Regular menstrual cycles (every 26-35 days)

 -  Last term pregnancy at least 42 days prior to Visit 1, and have had at least one
 normal menstrual period (typical in duration and amount of flow for the subject) since
 her last pregnancy

 -  Post-menarcheal and pre-menopausal

 -  At least one normal menstrual period (typical in duration and amount of flow for the
 subject) since having undergone uterines urgery or removal of an IUD, Norplant,
 DepoProvera or other hormonal injectables or implants.

 Exclusion Criteria:

 -  History or presence of disorders commonly accepted as contraindications to steroid
 hormonal therapy

 -  Previously discontinued ORTHO TRI-CYCLEN LO or YAZ due to breakthrough bleeding

 -  Pregnant or lactating

 -  Body mass index (BMI) of >40kg/m2

 -  Clinical evidence of carcinoma or other malignancy (history of basal cell carcinoma of
 the skin is not exclusionary)

 -  History of alcohol or drug abuse in the investigator's judgment based on history and
 physical examination (within 12 months prior to Visit 1)

 -  Significant depression or psychiatric disease in the investigator's judgment based on
 history and physical examination which would result in an unreliable patient

 -  Patient deemed by the investigator to have questionable reliability in her ability to
 comply with the protocol and provide accurate information

 -  Have any medical condition or planned surgical procedure which, in the opinion of the
 investigator, may be exacerbated by treatment with study medication or a patient
 receiving any concurrent therapy that could be affected by treatment with study
 medication

 -  Disallowed therapies: currently taking therapeutic anticoagulants (e.g,. Coumadin,
 Heparin) or have a bleeding disorder (e.g. von Willebrand's Disease), DepoProvera or
 other hormonal injectables in the six months before Visit 1, currently have Norplant
 or other hormonal implants in place, or have had removal of Norplant within 60 days
 prior to Visit 1, used a steroid-containing IUD within 3 months prior to Visit 1

 -  Or current use of an IUD

 -  Consistently elevated blood pressure defined as sitting systolic BP>140 mmHg or
 diastolic BP>90 mmHg

 -  Have an untreated thyroid disorder in the investigator's judgment based on history and
 physical examination

 -  unable to swallow solid, oral dosage forms whole with the aid of water (participants
 may not chew, divide, dissolve, or crush the study drug)

 -  Patients who in the opinion of the investigator should not be enrolled in the study
 based on the product labeling for ORTHO TRI-CYCLEN LO and YAZ including potential
 drug-drug interactions

 -  Have received an experimental drug or used an experimental medical device within 30
 days before the planned start of treatment