Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Contraception Desired

Intervention / Treatment
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* Drug: NuvaRing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quick start<br>Start contraceptive method (NuvaRing) day of enrollment | Drug: NuvaRing<br>* Initiation of NuvaRing for contraception<br>* Other names: contraceptive vaginal ring;|
| Active Comparator: Traditional start<br>Start contraceptive method (NuvaRing) after next menses (per package insert) | Drug: NuvaRing<br>* Initiation of NuvaRing for contraception<br>* Other names: contraceptive vaginal ring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation With the Contraceptive Method | Participants reporting continuation with contraceptive method at 3 months | 3 months | 
| Method Continuation at 6 Months | Participants reporting continuation of method at 6 months | 6 months | 
| Method Continuation at 12 Months | Participants reporting continuation with method at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Number of pregnancies reported | 3,6, and 12 mo | 
| Bleeding Profile |  | 3, 6, and 12 months | 
| Patient Satisfaction | Rating of patient satisfaction with method | 3, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Adolescents, Contraceptive vaginal ring, Quick start