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

NCT ID: NCT00269620

Last Updated: 2008-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-12-31

Brief Summary

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.

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®.

Conditions

Contraception

Keywords

contraceptive vaginal ring; contraceptive patch; oral contraceptives; acceptability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

OrthoEvra

Group Type: EXPERIMENTAL

ethinyl estradiol/norelgestromin transdermal contraceptive

Intervention Type: DRUG

contraceptive patch worn for 7 days and replaced for use for 3 consecutive weeks followed by a one-week patch free interval

1

NuvaRing

Group Type: EXPERIMENTAL

ethinyl estradiol/etonogestrel vaginal ring

Intervention Type: DRUG

vaginal ring for cyclic use (3 weeks in, 1 week out)

Interventions

ethinyl estradiol/etonogestrel vaginal ring

vaginal ring for cyclic use (3 weeks in, 1 week out)

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Nuvaring; OrthoEvra

Eligibility 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

University of Pittsburgh

Principal Investigators

Mitchell D Creinin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh/Magee-Womens Hospital

Locations

Boston University

Boston, Massachusetts, United States

Columbia University

New York, New York, United States

UCLA-Harbor

Los Angeles, California, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins

Baltimore, Maryland, United States

Oregon Health Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

References

Creinin MD, Meyn LA, Borgatta L, Barnhart K, Jensen J, Burke AE, Westhoff C, Gilliam M, Dutton C, Ballagh SA. Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial. Obstet Gynecol. 2008 Feb;111(2 Pt 1):267-77. doi: 10.1097/01.AOG.0000298338.58511.d1.

Reference Type: RESULT

PMID: 18238962 (View on PubMed)

Gracia CR, Sammel MD, Charlesworth S, Lin H, Barnhart KT, Creinin MD. Sexual function in first-time contraceptive ring and contraceptive patch users. Fertil Steril. 2010 Jan;93(1):21-8. doi: 10.1016/j.fertnstert.2008.09.066. Epub 2008 Oct 31.

Reference Type: DERIVED

PMID: 18976753 (View on PubMed)

Other Identifiers

pittirb0503164

Identifier Type: -

Identifier Source: org_study_id