Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Contraception Desired	Drug: NuvaRing	Not Applicable

Detailed Description:

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Prevention
Official Title:	"Quick Start" Initiation of the Contraceptive Vaginal Ring in Adolescents: A Randomized Controlled Trial
Study Start Date :	February 2007
Actual Primary Completion Date :	July 2009
Actual Study Completion Date :	July 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Quick start; Start contraceptive method (NuvaRing) day of enrollment	Drug: NuvaRing; Initiation of NuvaRing for contraception; Other Name: contraceptive vaginal ring
Active Comparator: Traditional start; Start contraceptive method (NuvaRing) after next menses (per package insert)	Drug: NuvaRing; Initiation of NuvaRing for contraception; Other Name: contraceptive vaginal ring

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Continuation With the Contraceptive Method [ Time Frame: 3 months ]
   Participants reporting continuation with contraceptive method at 3 months
2. Method Continuation at 6 Months [ Time Frame: 6 months ]
   Participants reporting continuation of method at 6 months
3. Method Continuation at 12 Months [ Time Frame: 12 months ]
   Participants reporting continuation with method at 12 months

Secondary Outcome Measures :

1. Pregnancy [ Time Frame: 3,6, and 12 mo ]
   Number of pregnancies reported
2. Bleeding Profile [ Time Frame: 3, 6, and 12 months ]
3. Patient Satisfaction [ Time Frame: 3, 6, and 12 months ]
   Rating of patient satisfaction with method

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

American College of Obstetricians and Gynecologists

Bayer

Investigators

Principal Investigator:	Nicole W Karjane, MD	Virginia Commonwealth University

More Information

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Publications:

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.

Novák 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.

Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00369967 History of Changes
Other Study ID Numbers:	5120008FN
First Posted:	August 30, 2006
Results First Posted:	July 22, 2016
Last Update Posted:	July 22, 2016
Last Verified:	June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	Not planned.

Keywords provided by Virginia Commonwealth University:

Contraception; Adolescents; Contraceptive vaginal ring; Quick start

Additional relevant MeSH terms:

Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs