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

NCT00269620 | Completed Phase 4

• 1 other identifier: pittirb0503164
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 10

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.

Conditions

Contraception

Keywords

contraceptive vaginal ring; contraceptive patch; oral contraceptives; acceptability

Outcome Measures

Primary Outcomes (1)

• continuation into the fourth cycle

  four months

Secondary Outcomes (7)

• planned continuation after four cycles

  four months

• compare side effect rates

  four months

• compare acceptability

  four months

• evaluate changes in sexual functioning as compared to baseline

  four months

• compare changes in Nugent's scores (evaluations for bacterial vaginosis [BV])

  four months

Study Arms (2)

2

EXPERIMENTAL

OrthoEvra

Drug: ethinyl estradiol/norelgestromin transdermal contraceptive

1

EXPERIMENTAL

NuvaRing

Drug: ethinyl estradiol/etonogestrel vaginal ring

Interventions

ethinyl estradiol/etonogestrel vaginal ring DRUG

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

Also known as: Nuvaring

1

ethinyl estradiol/norelgestromin transdermal contraceptive DRUG

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

Also known as: OrthoEvra

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Organon: collaborator

Study Sites (10)

UCLA-Harbor

Los Angeles, California, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

Johns Hopkins

Baltimore, Maryland, United States

Location

Boston University

Boston, Massachusetts, United States

Location

Columbia University

New York, New York, United States

Location

Oregon Health Science University

Portland, Oregon, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, United States

Location

University of Wisconsin

Madison, Wisconsin, United States

Location

Related Publications (2)

• 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.

  PMID: 18238962 RESULT

• 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.

  PMID: 18976753 DERIVED

MeSH Terms

Interventions

Ethinyl Estradiol; NuvaRing

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mitchell D Creinin, MD

  University of Pittsburgh/Magee-Womens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: December 23, 2005
• Study Start: June 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 21, 2008

Record last verified: 2008-10

Locations

US (10)