PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra

This study has been completed.
Sponsor:
Collaborators:
Magee-Womens Hospital
Organon
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00269620
First received: September 12, 2005
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

This is an open-label prospective, multicenter, randomized trial to compare continuation rates into the fourth cycle of women using either the NuvaRing or OrthoEvra. Five hundred women will be recruited at 9 centers nationwide to be randomly assigned to use either the NuvaRing or OrthoEvra for four months. Women must either be on the pill or have recently stopped the pill and be relatively satisfied with oral contraceptive use to qualify for enrollment. Two visits and two phone calls will be required.


Condition Intervention Phase
Contraception
Drug: ethinyl estradiol/etonogestrel vaginal ring
Drug: ethinyl estradiol/norelgestromin transdermal contraceptive
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Multicenter Trial to Evaluate Continuation Rates, Side Effects and Acceptability of NuvaRing Versus OrthoEvra

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • continuation into the fourth cycle [ Time Frame: four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • planned continuation after four cycles [ Time Frame: four months ] [ Designated as safety issue: No ]
  • compare side effect rates [ Time Frame: four months ] [ Designated as safety issue: Yes ]
  • compare acceptability [ Time Frame: four months ] [ Designated as safety issue: No ]
  • evaluate changes in sexual functioning as compared to baseline [ Time Frame: four months ] [ Designated as safety issue: No ]
  • compare changes in Nugent's scores (evaluations for bacterial vaginosis [BV]) [ Time Frame: four months ] [ Designated as safety issue: Yes ]
  • evaluate contraceptive efficacy [ Time Frame: four months ] [ Designated as safety issue: No ]
  • evaluate number of phone calls and interim visits due to method related problems [ Time Frame: four months ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: June 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
OrthoEvra
Drug: ethinyl estradiol/norelgestromin transdermal contraceptive
contraceptive patch worn for 7 days and replaced for use for 3 consecutive weeks followed by a one-week patch free interval
Other Name: OrthoEvra
Experimental: 1
NuvaRing
Drug: ethinyl estradiol/etonogestrel vaginal ring
vaginal ring for cyclic use (3 weeks in, 1 week out)
Other Name: Nuvaring

Detailed Description:

The present study is designed primarily to compare continuation rates after three months of use of NuvaRing® and OrthoEvra® in women who had been previously using oral contraceptives. The study attempts to evaluate the possible choices for women who are content with their current or recent method of oral combined hormonal contraception but would be considering a change in their method to a non-daily delivery system. Continuation rates should demonstrate the overall acceptance of both methods as women who find that the method is convenient and has few side effects are likely to continue using the method. Sexual functioning is another important aspect to investigate. The Female Sexual Function Index (FSFI) will be administered to participants along with the planned study questionnaires at the enrollment visit and at the final visit. Additionally, this study will compare side effects, the incidence of bacterial vaginosis, and direct measures of acceptability between the two groups. Efficacy over the three-month study period will also be evaluated; however, since both methods are highly effective and the study is relatively short in duration, the study is not designed to be large enough to detect any differences in efficacy.

This open-label, prospective, multicenter, randomized comparative trial will be conducted in approximately 500 women in the United States who are currently or recently have used a combined oral contraceptive and have no past experience using NuvaRing® or OrthoEvra®. Subjects will be enrolled once they have provided informed consent, had a baseline blood pressure and breast and pelvic examinations, and had negative endocervical testing for gonorrhea and chlamydia. Participants will be randomized to use either NuvaRing® or OrthoEvra® for four continuous cycles beginning with the first day of menses following the enrollment visit. Subjects are to contact the research office by phone to confirm that they initiated the method as instructed. The researchers will contact subjects during the second week of the second cycle of study medication. A final visit will occur during the first week of the fourth cycle of study medication (or sooner if the subject requires or requests early discontinuation). An acceptability questionnaire will be administered at the subject's final visit. This questionnaire has been modified from a questionnaire validated in women using NuvaRing®.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently or recently (within 3 months of enrollment) using oral contraceptives and content with use.
  • In good general health with no contraindications to combined hormonal contraceptive use; premenopausal; and willing to be randomly assigned to use the patch or ring for the next 4 cycles.
  • Willing to forego the use of vaginal products and anal intercourse for study duration; if heterosexually active, must be with a single partner for at least the past 3 months and not planning a change during study participation.

Exclusion Criteria:

  • Known or suspected pregnancy; hypersensitivity to NuvaRing or OrthoEvra; present or use within 2 months of liver-enzyme-inducing medications or St. John's Wort; breastfeeding currently or within 60 days; abortion or delivery of pregnancy at 15 weeks or greater within 49 days; or abortion within 21 days at 14 weeks or less.
  • Previous use of patch or ring for contraception; use of an injectable contraceptive within 6 months; use of an investigational drug within 2 months; or planning a pregnancy within 6 months.
  • Diagnosis of gonorrhea or chlamydia at screening, or any vaginal or cervical abnormality that would require colposcopy during the course of the study.
  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: NCT00269620

Locations
United States, California
UCLA-Harbor
Los Angeles, California, United States
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States
United States, Massachusetts
Boston University
Boston, Massachusetts, United States
United States, New York
Columbia University
New York, New York, United States
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
University of Pittsburgh
Magee-Womens Hospital
Organon
Investigators
Principal Investigator: Mitchell D Creinin, MD University of Pittsburgh/Magee-Womens Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mitchell Creinin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00269620     History of Changes
Other Study ID Numbers: pittirb0503164
Study First Received: September 12, 2005
Last Updated: October 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
contraceptive vaginal ring
contraceptive patch
oral contraceptives
acceptability

Additional relevant MeSH terms:
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
3-keto-desogestrel
Norelgestromin
Desogestrel
Ortho Evra
Norgestrel
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral
Progestins
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on July 24, 2014