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

NCT00357981 | Withdrawn

• 1 other identifier: H10857-25721-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysmenorrhea; Menstruation Disturbances; Menstruation Disorders

Keywords

Contraceptive patch; menstruation; economics

Outcome Measures

Primary Outcomes (2)

• Birth control satisfaction after four months of patch use

  Four months

• Health-related work productivity scales after four months of patch use

  Four months

Study Arms (1)

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.

Drug: ORTHO EVRA, the contraceptive patch

Interventions

ORTHO EVRA, the contraceptive patch DRUG

ORTHO EVRA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Ortho-McNeil, Inc.: collaborator

Related Publications (6)

• 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.

  PMID: 12383534 BACKGROUND

• 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.

  PMID: 3287908 BACKGROUND

• 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.

  PMID: 10943579 BACKGROUND

• 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.

  PMID: 14550999 BACKGROUND

• 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.

  PMID: 8633735 BACKGROUND

• Kaunitz AM. Menstruation: choosing whether...and when. Contraception. 2000 Dec;62(6):277-84. doi: 10.1016/s0010-7824(00)00182-7.

  PMID: 11239613 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Menstruation Disturbances

Interventions

Ortho Evra

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Eleanor Drey, MD, EdM

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 28, 2006
• Last Updated: August 29, 2013

Record last verified: 2013-08