An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cyclic regimen

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norelgestromin; Norgestrel; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Patients in good health as confirmed by medical history

• not pregnant as demonstrated by negative urine pregnancy test

• completed their last term pregnancy at least 42 days prior to Screening and at least one normal menstrual period since last pregnancy

• not lactating

• post-menarcheal and pre-menopausal

Exclusion Criteria:

• History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products

• treatment with continuous oral contraception within three months of study

• previous use of contraceptive patch including norelgestromin/ethinyl estradiol

• patients who are amenorrheic (abnormal suppression or absence of menstruation)

• recent history of alcohol or substance abuse

• skin conditions resulting in oily, irritated or damaged skin at potential sites of application