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

August 27, 2013 updated by: University of California, San Francisco

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Birth control satisfaction after four months of patch use
Time Frame: Four months
Four months
Health-related work productivity scales after four months of patch use
Time Frame: Four months
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Ortho-McNeil, Inc.

Investigators

  • Principal Investigator: Eleanor Drey, MD, EdM, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 26, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 28, 2006

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10857-25721-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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