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Sponsors and Collaborators: |
University of Pittsburgh Magee-Womens Hospital Organon |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00269620 |
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 |
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Contraception |
Drug: ethinyl estradiol/etonogestrel vaginal ring Drug: ethinyl estradiol/norelgestromin transdermal contraceptive |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | An Open-Label, Randomized, Multicenter Trial to Evaluate Continuation Rates, Side Effects and Acceptability of NuvaRing Versus OrthoEvra |
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 |
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2: Experimental
OrthoEvra
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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
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1: Experimental
NuvaRing
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Drug: ethinyl estradiol/etonogestrel vaginal ring
vaginal ring for cyclic use (3 weeks in, 1 week out)
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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®.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Magee-Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States | |
United States, Virginia | |
Eastern Virginia Medical School | |
Norfolk, Virginia, United States | |
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States |
Principal Investigator: | Mitchell D Creinin, MD | University of Pittsburgh/Magee-Womens Hospital |
Responsible Party: | University of Pittsburgh ( Mitchell Creinin, MD ) |
Study ID Numbers: | pittirb0503164 |
Study First Received: | September 12, 2005 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00269620 |
Health Authority: | United States: Institutional Review Board |
contraceptive vaginal ring contraceptive patch oral contraceptives acceptability |
Norgestrel Norelgestromin Desogestrel Benzoates Estradiol 3-benzoate Estradiol valerate |
Ethinyl Estradiol Ortho Evra Estradiol 17 beta-cypionate Polyestradiol phosphate 3-keto-desogestrel Estradiol |
Estrogens Contraceptive Agents Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents |
Hormones Pharmacologic Actions Contraceptives, Oral, Combined Therapeutic Uses Progestins Contraceptives, Oral, Synthetic |