Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
Condition: Contraception
Intervention: Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norgestimate; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 355.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: contraception; bleeding; cycle control

Summary:

      The purpose of this study in healthy sexually active females is to evaluate the cycle control
      with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.
    

Eligibility criteria:

        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