Continuous Use of the Contraceptive Patch and the Personal Economic Impact. - Full Text View

Sponsor:	University of California, San Francisco
Collaborator:	Ortho-McNeil, Inc.
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00357981

Purpose

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.

Condition	Intervention
Dysmenorrhea Menstruation Disturbances Menstruation Disorders	Drug: ORTHO EVRA, the contraceptive patch

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Patient Experiences Using Evra for Management of Menstrual Related Symptoms.

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

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

Estimated Enrollment:

30

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357981

Locations

United States, California
UCSF/MZ Women's Health
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

Ortho-McNeil, Inc.

Investigators

Principal Investigator:

Eleanor Drey, MD, EdM

University of California, San Francisco

More Information

Publications:

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

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

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.

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.

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.

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

ClinicalTrials.gov Identifier:	NCT00357981 History of Changes
Other Study ID Numbers:	H10857-25721-01
Study First Received:	July 26, 2006
Last Updated:	May 19, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

Contraceptive patch
menstruation
economics

Additional relevant MeSH terms:

Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Contraceptive Agents
Ortho Evra

Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 24, 2012