Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents



Status:Archived
Conditions:Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011

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"Quick Start" Initiation of the Contraceptive Vaginal Ring in Adolescents: A Randomized Controlled Trial


We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in
adolescents seeking birth control will improve compliance compared to traditional start. We
will conduct a randomized controlled trial comparing "quick start" to traditional start
initiation of the contraceptive vaginal ring in adolescents seeking birth control. The
primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes
include abnormal bleeding, product satisfaction, and adverse events.


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.


We found this trial at
2
sites
Richmond, Virginia 23221
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Richmond, VA
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Richmond, VA
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