Skip to content

Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00369967
Enrollment
48
Registered
2006-08-30
Start date
2007-02-28
Completion date
2010-07-31
Last updated
2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception Desired

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

American College of Obstetricians and Gynecologists
CollaboratorOTHER
Bayer
CollaboratorINDUSTRY
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 21 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Continuation With the Contraceptive Method3 monthsParticipants reporting continuation with contraceptive method at 3 months
Method Continuation at 6 Months6 monthsParticipants reporting continuation of method at 6 months
Method Continuation at 12 Months12 monthsParticipants reporting continuation with method at 12 months

Secondary

MeasureTime frameDescription
Pregnancy3,6, and 12 moNumber of pregnancies reported
Bleeding Profile3, 6, and 12 months
Patient Satisfaction3, 6, and 12 monthsRating of patient satisfaction with method

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total48

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up2312

Baseline characteristics

CharacteristicQuick StartTotalTraditional Start
Age, Categorical
<=18 years
6 Participants11 Participants5 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants37 Participants26 Participants
Age, Continuous18 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
11 Participants29 Participants18 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants2 Participants
Race (NIH/OMB)
White
5 Participants16 Participants11 Participants
Region of Enrollment
United States
17 participants48 participants31 participants
Sex: Female, Male
Female
17 Participants48 Participants31 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 310 / 17
serious
Total, serious adverse events
0 / 310 / 17

Outcome results

Primary

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

ArmMeasureValue (NUMBER)
Quick StartContinuation With the Contraceptive Method5 participants
Traditional StartContinuation With the Contraceptive Method11 participants
Primary

Method Continuation at 12 Months

Participants reporting continuation with method at 12 months

Time frame: 12 months

Population: Participants enrolled

ArmMeasureValue (NUMBER)
Quick StartMethod Continuation at 12 Months0 participants
Traditional StartMethod Continuation at 12 Months2 participants
Primary

Method Continuation at 6 Months

Participants reporting continuation of method at 6 months

Time frame: 6 months

Population: Participants enrolled

ArmMeasureValue (NUMBER)
Quick StartMethod Continuation at 6 Months7 participants
Traditional StartMethod Continuation at 6 Months2 participants
Secondary

Bleeding Profile

Time frame: 3, 6, and 12 months

Population: None of the participants returned their menstrual calendars to assess this outcome

Secondary

Patient Satisfaction

Rating of patient satisfaction with method

Time frame: 3, 6, and 12 months

Population: None of the participants returned their satisfaction survey

Secondary

Pregnancy

Number of pregnancies reported

Time frame: 3,6, and 12 mo

Population: There were no reported pregnancies during the study period

ArmMeasureValue (NUMBER)
Quick StartPregnancy0 participants
Traditional StartPregnancy0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026