Continuous Use of the Contraceptive Patch and the Personal Economic Impact.

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Dr. Eleanor Drey in the Department of Obstetrics, Gynecology and Reproductive Sciences UCSF is conducting a study to examine the personal and economic impact of continuous use of ORTHO EVRA, the contraceptive patch, on menstrual related symptoms for women who report having severe menstrual related symptoms.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Ortho-McNeil, Inc.
• Treatments: Contraceptive Agents; Ortho Evra

Criteria

Inclusion Criteria:

• Healthy, women 18 through 40 years of age at the time of enrollment who have severe menstrual related symptoms

• Willing and able to comply with the study protocol

• Has not used oral contraceptives, vaginal rings, or injectable contraceptives during the last month and has had one regular menstrual period preceding enrollment OR is within seven days post induced abortion

• Has been determined to be eligible for hormonal contraceptive use

• Willing and able to be contacted by research staff.

Exclusion Criteria:

• Does not speak or read English

• Is breastfeeding

• Has contraindications to use of estrogen-containing contraceptives including thrombophlebitis or thromboembolic disorders including a past history of deep vein thrombophlebitis or thromboembolic disorders

• Cerebrovascular or coronary artery disease

• Known or suspected carcinoma of the breast, endometrium or suspected estrogen-dependent neoplasia

• Undiagnosed abnormal genital bleeding

• Biliary tract disease

• Cholestatic jaundice of pregnancy or jaundice with prior contraceptive steroid use

• Hepatitis

• Cirrhosis

• Hepatic adenomas or carcinoma

• Hypertension (>140 systolic or >90 diastolic)

• Diabetes

• Migraine with focal neurologic symptoms

• Is pregnant or less than 3 months postpartum

• Concurrent use of medications that induce liver enzymes

• Has severe or chronic constipation

• Drug or alcohol abuse (current or within the last 12 months)

• Unable or unwilling to comply with protocol

• Is HIV-positive

• Has history or presence of cancer

• Treatment (other than hormonal contraception) has been recommended for menstrual symptoms

• Taking prescription medication because of menstrual related symptoms