Contraception Desired
Conditions
Keywords
Contraception, Adolescents, Contraceptive vaginal ring, Quick start
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.
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.
Interventions
Initiation of NuvaRing for contraception
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuation With the Contraceptive Method | 3 months | Participants reporting continuation with contraceptive method at 3 months |
| Method Continuation at 6 Months | 6 months | Participants reporting continuation of method at 6 months |
| Method Continuation at 12 Months | 12 months | Participants reporting continuation with method at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 3,6, and 12 mo | Number of pregnancies reported |
| Bleeding Profile | 3, 6, and 12 months | — |
| Patient Satisfaction | 3, 6, and 12 months | Rating of patient satisfaction with method |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional Start NuvaRing: Initiation of NuvaRing for contraception per package insert | 31 |
| Quick Start NuvaRing: Initiation of NuvaRing for contraception on day of enrollment | 17 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 23 | 12 |
Baseline characteristics
| Characteristic | Quick Start | Total | Traditional Start |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 11 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 37 Participants | 26 Participants |
| Age, Continuous | 18 years STANDARD_DEVIATION 2.1 | 18 years STANDARD_DEVIATION 1.9 | 19 years STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 29 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 16 Participants | 11 Participants |
| Region of Enrollment United States | 17 participants | 48 participants | 31 participants |
| Sex: Female, Male Female | 17 Participants | 48 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 17 |
| serious Total, serious adverse events | 0 / 31 | 0 / 17 |
Outcome results
Continuation With the Contraceptive Method
Participants reporting continuation with contraceptive method at 3 months
Time frame: 3 months
Population: Number using method at 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quick Start | Continuation With the Contraceptive Method | 5 participants |
| Traditional Start | Continuation With the Contraceptive Method | 11 participants |
Method Continuation at 12 Months
Participants reporting continuation with method at 12 months
Time frame: 12 months
Population: Participants enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quick Start | Method Continuation at 12 Months | 0 participants |
| Traditional Start | Method Continuation at 12 Months | 2 participants |
Method Continuation at 6 Months
Participants reporting continuation of method at 6 months
Time frame: 6 months
Population: Participants enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quick Start | Method Continuation at 6 Months | 7 participants |
| Traditional Start | Method Continuation at 6 Months | 2 participants |
Bleeding Profile
Time frame: 3, 6, and 12 months
Population: None of the participants returned their menstrual calendars to assess this outcome
Patient Satisfaction
Rating of patient satisfaction with method
Time frame: 3, 6, and 12 months
Population: None of the participants returned their satisfaction survey
Pregnancy
Number of pregnancies reported
Time frame: 3,6, and 12 mo
Population: There were no reported pregnancies during the study period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quick Start | Pregnancy | 0 participants |
| Traditional Start | Pregnancy | 0 participants |