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

Dysmenorrhea Clinical Trial

Official title:

Patient Experiences Using Evra for Management of Menstrual Related Symptoms.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00357981
• Other study ID #: H10857-25721-01
• Status: Withdrawn
• Phase: N/A
• First received: July 26, 2006
• Last updated: August 27, 2013

Study information

• Verified date: August 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Menstruation Disorders
• Menstruation Disturbances

Intervention

Drug:
• ORTHO EVRA, the contraceptive patch

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Ortho-McNeil, Inc.

References & Publications (6)

Braunstein JB, Hausfeld J, Hausfeld J, London A. Economics of reducing menstruation with trimonthly-cycle oral contraceptive therapy: comparison with standard-cycle regimens. Obstet Gynecol. 2003 Oct;102(4):699-708. — View Citation

Côté I, Jacobs P, Cumming D. Work loss associated with increased menstrual loss in the United States. Obstet Gynecol. 2002 Oct;100(4):683-7. — View Citation

Dawood MY. Nonsteroidal anti-inflammatory drugs and changing attitudes toward dysmenorrhea. Am J Med. 1988 May 20;84(5A):23-9. — View Citation

Kaunitz AM. Menstruation: choosing whether...and when. Contraception. 2000 Dec;62(6):277-84. Review. — View Citation

Kjerulff KH, Erickson BA, Langenberg PW. Chronic gynecological conditions reported by US women: findings from the National Health Interview Survey, 1984 to 1992. Am J Public Health. 1996 Feb;86(2):195-9. — View Citation

Kristjansdottir J, Johansson ED, Ruusuvaara L. The cost of the menstrual cycle in young Swedish women. Eur J Contracept Reprod Health Care. 2000 Jun;5(2):152-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth control satisfaction after four months of patch use		Four months	No
Primary	Health-related work productivity scales after four months of patch use		Four months	No