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

This study has been withdrawn prior to enrollment.
(Both sponsor and UCSF decided this study was not clinical relevant at this time)
Sponsor:
Collaborator:
Ortho-McNeil, Inc.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00357981
First received: July 26, 2006
Last updated: August 27, 2013
Last verified: August 2013
  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:


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

Primary Outcome Measures:
  • Birth control satisfaction after four months of patch use [ Time Frame: Four months ] [ Designated as safety issue: No ]
  • Health-related work productivity scales after four months of patch use [ Time Frame: Four months ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
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.

Drug: ORTHO EVRA, the contraceptive patch

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00357981     History of Changes
Other Study ID Numbers: H10857-25721-01
Study First Received: July 26, 2006
Last Updated: August 27, 2013
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 September 30, 2014