Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents
Information source: Virginia Commonwealth University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adolescents Seeking Contraception
Intervention: NuvaRing (Drug)
Phase: Phase 4
Sponsored by: Virginia Commonwealth University
Official(s) and/or principal investigator(s):
Nicole W Karjane, MD, Principal Investigator, Affiliation: Virginia Commonwealth University
Nicole W Karjane, MD, Phone: 804-828-1804, Email: firstname.lastname@example.org
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.
Official title: "Quick Start" Initiation of the Contraceptive Vaginal Ring in Adolescents: A Randomized Controlled Trial
Study design: Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Primary outcome: Continuation with the contraceptive method
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.
Minimum age: 15 Years.
Maximum age: 21 Years.
Inclusion Criteria: 1) female aged 15 through 21 presenting for contraception; 2) willing
to use the NuvaRing as their contraceptive method; 3) English-speaking; 4) up to date on
routine health maintenance screening (pap smear within 3 years of initiation of sexual
intercourse and Gonorrhea/ Chlamydia testing yearly or with each new partner); and 5) able
to read and understand the consent form.
Exclusion Criteria: 1) are pregnant; 2) have a contraindication to hormonal
contraception; 3) are unwilling to use NuvaRing as their contraceptive method; 4) are
currently using any hormonal contraceptive or have used one within past 2 months; 5) have
used emergency contraception in the past 7 days; 6) have had unprotected intercourse in
the past 10 days; 7) have untreated Gonorrhea or Chlamydia; or 8) are unable to give
informed consent because of psychiatric or cognitive problems.
Locations and Contacts
Nicole W Karjane, MD, Phone: 804-828-1804, Email: email@example.com
Virginia Commonwealth University Medical Center, Richmond, Virginia 23298, United States; Recruiting
Richard Brookman, MD, Sub-Investigator
Nicole W Karjane, MD, Principal Investigator
Virginia League of Planned Parenthood, Richmond, Virginia 23221, United States; Recruiting
Paulette McElwain, Phone: 804-254-1760, Email: firstname.lastname@example.org
Zibners A, Cromer BA, Hayes J. Comparison of continuation rates for hormonal contraception among adolescents. J Pediatr Adolesc Gynecol. 1999 May;12(2):90-4.
Rosenberg M, Waugh MS. Causes and consequences of oral contraceptive noncompliance. Am J Obstet Gynecol. 1999 Feb;180(2 Pt 2):276-9.
van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005 Sep;72(3):168-74.
Rivera R, Cabral de Mello M, Johnson SL, Chandra-Mouli V. Contraception for adolescents: social, clinical and service-delivery considerations. Int J Gynaecol Obstet. 2001 Nov;75(2):149-63.
Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception. 2003 Mar;67(3):187-94.
Oddsson K, Leifels-Fischer B, de Melo NR, Wiel-Masson D, Benedetto C, Verhoeven CH, Dieben TO. Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. Contraception. 2005 Mar;71(3):176-82.
Westhoff C, Kerns J, Morroni C, Cushman LF, Tiezzi L, Murphy PA. Quick start: novel oral contraceptive initiation method. Contraception. 2002 Sep;66(3):141-5.
Lara-Torre E, Schroeder B. Adolescent compliance and side effects with Quick Start initiation of oral contraceptive pills. Contraception. 2002 Aug;66(2):81-5.
Westhoff C, Morroni C, Kerns J, Murphy PA. Bleeding patterns after immediate vs. conventional oral contraceptive initiation: a randomized, controlled trial. Fertil Steril. 2003 Feb;79(2):322-9.
Westhoff C, Osborne LM, Schafer JE, Morroni C. Bleeding patterns after immediate initiation of an oral compared with a vaginal hormonal contraceptive. Obstet Gynecol. 2005 Jul;106(1):89-96.
Starting date: February 2007
Last updated: July 5, 2007