Clinical trial NCT00269620: PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra
Official title: An Open-Label, Randomized, Multicenter Trial to Evaluate Continuation Rates, Side Effects and Acceptability of NuvaRing Versus OrthoEvra
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: contraceptive vaginal ring
contraceptive patch
oral contraceptives
acceptability
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2005-12-23
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.

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.

Primary outcomes:
measure: continuation into the fourth cycle
timeFrame: four months
Secondary outcomes:
measure: planned continuation after four cycles
timeFrame: four months
measure: compare side effect rates
timeFrame: four months
measure: compare acceptability
timeFrame: four months
measure: evaluate changes in sexual functioning as compared to baseline
timeFrame: four months
measure: compare changes in Nugent's scores (evaluations for bacterial vaginosis [BV])
timeFrame: four months
measure: evaluate contraceptive efficacy
timeFrame: four months
measure: evaluate number of phone calls and interim visits due to method related problems
timeFrame: four months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA-Harbor
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Pittsburgh/Magee-Womens Hospital
name: Mitchell D Creinin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.