ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00357981
Recruitment Status : Withdrawn (Both sponsor and UCSF decided this study was not clinical relevant at this time)
First Posted : July 28, 2006
Last Update Posted : August 29, 2013
Sponsor:
Collaborator:
Ortho-McNeil, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

July 26, 2006
July 28, 2006
August 29, 2013
Not Provided
Not Provided
  • 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 ]
  • Birth control satisfaction after four months of patch use
  • Health-related work productivity scales after four months of patch use
Complete list of historical versions of study NCT00357981 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Continuous Use of the Contraceptive Patch and the Personal Economic Impact.
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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Dysmenorrhea
  • Menstruation Disturbances
  • Menstruation Disorders
Drug: ORTHO EVRA, the contraceptive patch
Experimental: 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.

Intervention: Drug: ORTHO EVRA, the contraceptive patch

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
30
Not Provided
Not Provided

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
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00357981
H10857-25721-01
Not Provided
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
Ortho-McNeil, Inc.
Principal Investigator: Eleanor Drey, MD, EdM University of California, San Francisco
University of California, San Francisco
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP