search
Back to results

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

Primary Purpose

Dysmenorrhea, Menstruation Disturbances, Menstruation Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ORTHO EVRA, the contraceptive patch
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Contraceptive patch, menstruation, economics

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ORTHO EVRA

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2006
    Last Updated
    August 27, 2013
    Sponsor
    University of California, San Francisco
    Collaborators
    Ortho-McNeil, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00357981
    Brief Title
    Continuous Use of the Contraceptive Patch and the Personal Economic Impact.
    Official Title
    Patient Experiences Using Evra for Management of Menstrual Related Symptoms.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Both sponsor and UCSF decided this study was not clinical relevant at this time
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco
    Collaborators
    Ortho-McNeil, Inc.

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysmenorrhea, Menstruation Disturbances, Menstruation Disorders
    Keywords
    Contraceptive patch, menstruation, economics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ORTHO EVRA
    Arm Type
    Experimental
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    ORTHO EVRA, the contraceptive patch
    Primary Outcome Measure Information:
    Title
    Birth control satisfaction after four months of patch use
    Time Frame
    Four months
    Title
    Health-related work productivity scales after four months of patch use
    Time Frame
    Four months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eleanor Drey, MD, EdM
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12383534
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3287908
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10943579
    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. doi: 10.1080/13625180008500385.
    Results Reference
    background
    PubMed Identifier
    14550999
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8633735
    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. doi: 10.2105/ajph.86.2.195.
    Results Reference
    background
    PubMed Identifier
    11239613
    Citation
    Kaunitz AM. Menstruation: choosing whether...and when. Contraception. 2000 Dec;62(6):277-84. doi: 10.1016/s0010-7824(00)00182-7.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs