Official Title: “Patient Experiences Using Evra for Management of Menstrual Related Symptoms.”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

30 adult women, 18-40 years of age, will be recruited to participate in a six month study.

The focus of recruitment will be on women with menstrual-related symptoms who are currently working in physically demanding, low autonomous service jobs.

The approximate first two months of women's participation will be spent documenting baseline information about their health and well-being, work patterns and performance, and the economic impact of their menstruation. Subjects will then initiate two, two month intervals of continuous use of ORTHO EVRA.

Over this four month treatment period, subjects will document their health and well-being, work patterns and performance, and the economic impact of their menstruation while being treated with ORTHO EVRA. This will allow us to compare subjects' experiences pre- and post-treatment. The study's instruments will focus on eliciting information on the personal and economic costs of menstruation such as measuring time missed from work, changes in productivity and work satisfaction, and impact on quality of life.

Intervention(s) in this Clinical Trial

• Drug: ORTHO EVRA, the contraceptive patch

Primary Measures

• Birth control satisfaction after four months of patch use
• Health-related work productivity scales after four months of patch use

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of California, San Francisco

Overall Clinical Trial Officials and Contacts

Eleanor Drey, MD, EdM Principal Investigator University of California, San Francisco  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00357981

Study ID Number: H10857-25721-01

ClinicalTrials.gov Identifier: NCT00357981

Health Authority: United States: Food and Drug Administration