Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norgestimate; Norgestrel; Polyestradiol phosphate

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