Trial Outcomes & Findings for Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents (NCT NCT00369967)
NCT ID: NCT00369967
Last Updated: 2016-07-22
Results Overview
Participants reporting continuation with contraceptive method at 3 months
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
3 months
Results posted on
2016-07-22
Participant Flow
Participant milestones
| Measure |
Traditional Start
NuvaRing: Initiation of NuvaRing for contraception per package insert
|
Quick Start
NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
17
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
23
|
12
|
Reasons for withdrawal
| Measure |
Traditional Start
NuvaRing: Initiation of NuvaRing for contraception per package insert
|
Quick Start
NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
12
|
Baseline Characteristics
Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents
Baseline characteristics by cohort
| Measure |
Traditional Start
n=31 Participants
NuvaRing: Initiation of NuvaRing for contraception per package insert
|
Quick Start
n=17 Participants
NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
19 years
STANDARD_DEVIATION 1.7 • n=39 Participants
|
18 years
STANDARD_DEVIATION 2.1 • n=41 Participants
|
18 years
STANDARD_DEVIATION 1.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=39 Participants
|
17 participants
n=41 Participants
|
48 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Number using method at 3 months
Participants reporting continuation with contraceptive method at 3 months
Outcome measures
| Measure |
Quick Start
n=17 Participants
Start method day of enrollment
NuvaRing: Initiation of NuvaRing for contraception
|
Traditional Start
n=31 Participants
NuvaRing: Initiation of NuvaRing for contraception
|
|---|---|---|
|
Continuation With the Contraceptive Method
|
5 participants
|
11 participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants enrolled
Participants reporting continuation of method at 6 months
Outcome measures
| Measure |
Quick Start
n=31 Participants
Start method day of enrollment
NuvaRing: Initiation of NuvaRing for contraception
|
Traditional Start
n=17 Participants
NuvaRing: Initiation of NuvaRing for contraception
|
|---|---|---|
|
Method Continuation at 6 Months
|
7 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants enrolled
Participants reporting continuation with method at 12 months
Outcome measures
| Measure |
Quick Start
n=17 Participants
Start method day of enrollment
NuvaRing: Initiation of NuvaRing for contraception
|
Traditional Start
n=31 Participants
NuvaRing: Initiation of NuvaRing for contraception
|
|---|---|---|
|
Method Continuation at 12 Months
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 3,6, and 12 moPopulation: There were no reported pregnancies during the study period
Number of pregnancies reported
Outcome measures
| Measure |
Quick Start
n=17 Participants
Start method day of enrollment
NuvaRing: Initiation of NuvaRing for contraception
|
Traditional Start
n=31 Participants
NuvaRing: Initiation of NuvaRing for contraception
|
|---|---|---|
|
Pregnancy
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3, 6, and 12 monthsPopulation: None of the participants returned their menstrual calendars to assess this outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3, 6, and 12 monthsPopulation: None of the participants returned their satisfaction survey
Rating of patient satisfaction with method
Outcome measures
Outcome data not reported
Adverse Events
Traditional Start
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Quick Start
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place