Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||"Quick Start" Initiation of the Contraceptive Vaginal Ring in Adolescents: A Randomized Controlled Trial|
- Continuation with the contraceptive method [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
- Bleeding profile [ Time Frame: 3,6,and 12 mo ] [ Designated as safety issue: No ]
- pregnancy [ Time Frame: 3,6, and 12 mo ] [ Designated as safety issue: No ]
- product satisfaction [ Time Frame: 3,6,and 12 mo ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Quick start
Start method day of enrollment
Initiation of NuvaRing for contraception
|Active Comparator: Traditional start||
Initiation of NuvaRing for contraception
Pregnancy prevention is an important aspect of adolescent healthcare. Adherence to a chosen contraception method is essential to its success. Adolescents are notoriously poor at complying with oral contraceptives (OCs), with continuation rates at one year as low as 12% (1). In those patients who continue their contraceptive method, our best data estimates that the average OC user misses three pills per cycle (2). Given the already highly fluctuant serum hormone levels in OC users (3), this leaves poorly compliant users at greater risk for unintended pregnancy.
The contraceptive vaginal ring is a reliable method of contraception and may be particularly useful in the adolescent population because of its simple monthly dosing schedule (4). It is a combined hormonal contraceptive containing etonogestrel (a progesterone) and ethinyl estradiol (an estrogen), which are released continuously at low levels. The vaginal ring has been shown to have comparable efficacy and tolerability to OCs (5), but does not require daily dosing due to its novel drug delivery system. Studies have shown high rates of acceptability and satisfaction with vaginal ring usage in adult and adolescent women and a high rate of continuation using a traditional start method (6).
The "quick start" method of initiating use of OCs has been found to improve continuation rates and overall method satisfaction compared to traditional start in large studies of adult women (7) and also in small studies of adolescents (8) without significantly affecting incidence of breakthrough bleeding or patient satisfaction (9). "Quick start" contraceptive vaginal ring has been studied in women aged 18-40 years and found to have a more favorable bleeding profile than "quick start" Ortho-Tricyclen Lo (10). This decreased incidence of altered bleeding may be a more favorable benefit of "quick start" contraceptive vaginal ring in the adolescent population as well.
One of the biggest obstacles to use of the contraceptive vaginal ring in clinical practice is having the patient overcome the idea of vaginally inserting the ring, especially in the adolescent population (11). It seems logical that initiating the vaginal ring in the office via the "quick start" method may improve patient acceptance and comfort with the method, thus improving continuation rates in these patients compared to traditional initiation.
We propose to perform a randomized controlled trial comparing "quick start" to traditional start NuvaRing in adolescents. Subjects meeting inclusion criteria will be randomized to either start the method in the office immediately or start the method within 5 days of her next menstrual period. Subjects will follow up at 3, 6, and 12 months, at which time we will assess continuation, bleeding patterns, pregnancy, and patient satisfaction.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369967
|United States, Virginia|
|Virginia Commonwealth University Medical Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Nicole W Karjane, MD||Virginia Commonwealth University|