Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00369967 |
Recruitment Status :
Terminated
(difficulty in subject recruitment)
First Posted : August 30, 2006
Results First Posted : July 22, 2016
Last Update Posted : July 22, 2016
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contraception Desired | Drug: NuvaRing | Not Applicable |
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 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 |

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 |
- Continuation With the Contraceptive Method [ Time Frame: 3 months ]Participants reporting continuation with contraceptive method at 3 months
- Method Continuation at 6 Months [ Time Frame: 6 months ]Participants reporting continuation of method at 6 months
- Method Continuation at 12 Months [ Time Frame: 12 months ]Participants reporting continuation with method at 12 months
- Pregnancy [ Time Frame: 3,6, and 12 mo ]Number of pregnancies reported
- Bleeding Profile [ Time Frame: 3, 6, and 12 months ]
- Patient Satisfaction [ Time Frame: 3, 6, and 12 months ]Rating of patient satisfaction with method

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369967
United States, Virginia | |
Virginia Commonwealth University Medical Center | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Nicole W Karjane, MD | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00369967 |
Other Study ID Numbers: |
5120008FN |
First Posted: | August 30, 2006 Key Record Dates |
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. |
Contraception Adolescents Contraceptive vaginal ring Quick start |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |