DysmenorrheaNCT00357981
Continuous Use of the Contraceptive Patch and the Personal Economic Impact.
A study testing ORTHO EVRA, the contraceptive patch in people with Dysmenorrhea and Menstruation Disturbances, run by University of California, San Francisco.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Menstruation Disturbances, Menstruation Disorders
- What is being tested?
- ORTHO EVRA, the contraceptive patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
About this study
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.
Read the 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.
- Being tested
- ORTHO EVRA, the contraceptive patch
- Keywords
- Contraceptive patch, menstruation, economics
- Medical subject headings
- Dysmenorrhea, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORTHO EVRA, the contraceptive patchDrug
| Study group | Role | What they receive |
|---|---|---|
| ORTHO EVRA | Experimental | 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. Receives: Drug: ORTHO EVRA, the contraceptive patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth control satisfaction after four months of patch use
Measured: Four months
Health-related work productivity scales after four months of patch use
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
Why it stopped: Both sponsor and UCSF decided this study was not clinical relevant at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil, Inc.
- Responsible party
- Sponsor
- Investigators
- Eleanor Drey, MD, EdM, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357981
- Sponsor's protocol ID
- H10857-25721-01
- Status last verified
- Aug 2013
- First submitted
- 26 Jul 2006
- Last updated
- 29 Aug 2013
- Results posted
- No
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. doi: 10.1016/s0029-7844(02)02094-x.
PubMed 12383534Dawood 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.
PubMed 3287908Kristjansdottir 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.
PubMed 10943579Braunstein 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.
PubMed 14550999Kjerulff 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.
PubMed 8633735Kaunitz AM. Menstruation: choosing whether...and when. Contraception. 2000 Dec;62(6):277-84. doi: 10.1016/s0010-7824(00)00182-7.
PubMed 11239613
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experiences Using Evra for Management of Menstrual Related Symptoms.
- ClinicalTrials.gov ID
- NCT00357981
- Acronym / sponsor ID
- H10857-25721-01
- Keywords
- Contraceptive patch, menstruation, economics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Both sponsor and UCSF decided this study was not clinical relevant at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Ortho-McNeil, Inc.
- First posted
- 28 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORTHO EVRA | Experimental | Drug: ORTHO EVRA, the contraceptive patchThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORTHO EVRA, the contraceptive patch | Drug | ORTHO EVRA |
Primary outcome
Birth control satisfaction after four months of patch use
Time frame: Four months
Health-related work productivity scales after four months of patch use
Time frame: Four months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
- Background: PubMed 12383534Cote 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.
- Background: PubMed 3287908Dawood 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.
- Background: PubMed 10943579Kristjansdottir 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.
- Background: PubMed 14550999Braunstein 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.
- Background: PubMed 8633735Kjerulff 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.
- Background: PubMed 11239613Kaunitz AM. Menstruation: choosing whether...and when. Contraception. 2000 Dec;62(6):277-84. doi: 10.1016/s0010-7824(00)00182-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor Drey, MD, EdM principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing ORTHO EVRA, the contraceptive patch in people with Dysmenorrhea and Menstruation Disturbances, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth control satisfaction after four months of patch use (time frame: Four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00357981, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2013.