Continuous Use of the Contraceptive Patch and the Personal Economic Impact.
NCT ID: NCT00357981
Last Updated: 2013-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ORTHO EVRA
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.
ORTHO EVRA, the contraceptive patch
Interventions
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ORTHO EVRA, the contraceptive patch
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Ortho-McNeil, Inc.
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Eleanor Drey, MD, EdM
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Countries
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References
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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. doi: 10.1016/s0029-7844(02)02094-x.
Dawood MY. Nonsteroidal anti-inflammatory drugs and changing attitudes toward dysmenorrhea. Am J Med. 1988 May 20;84(5A):23-9. doi: 10.1016/0002-9343(88)90473-1.
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. doi: 10.1080/13625180008500385.
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. doi: 10.1016/s0029-7844(03)00738-5.
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. doi: 10.2105/ajph.86.2.195.
Kaunitz AM. Menstruation: choosing whether...and when. Contraception. 2000 Dec;62(6):277-84. doi: 10.1016/s0010-7824(00)00182-7.
Other Identifiers
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H10857-25721-01
Identifier Type: -
Identifier Source: org_study_id