Trial Outcomes & Findings for Acceptability of the NuvaRing Among Students (NCT NCT00635570)
NCT ID: NCT00635570
Last Updated: 2021-02-03
Results Overview
"Perfect use" was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
273 participants
Primary outcome timeframe
For the first 3 months
Results posted on
2021-02-03
Participant Flow
We recruited 276 participants between March 2006 and December 2008 at two Midwest university-based sites through passive (online and subway advertisements) and active recruitment (referrals from local clinics and health care providers).
We screened 276 participants, of whom 273 were eligible because 3 of them did not meet inclusion criteria.
Participant milestones
| Measure |
Contraceptive Vaginal Ring
Contraceptive vaginal ring (NuvaRing)
|
Oral Contraceptive Pill
Oral contraceptive pill (Ortho Tri-Cyclen Lo)
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
137
|
|
Overall Study
COMPLETED
|
121
|
126
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
Reasons for withdrawal
| Measure |
Contraceptive Vaginal Ring
Contraceptive vaginal ring (NuvaRing)
|
Oral Contraceptive Pill
Oral contraceptive pill (Ortho Tri-Cyclen Lo)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Did not complete survey
|
2
|
1
|
|
Overall Study
Early termination(No sexual activity)
|
1
|
1
|
Baseline Characteristics
Acceptability of the NuvaRing Among Students
Baseline characteristics by cohort
| Measure |
Contraceptive Vaginal Ring
n=136 Participants
Contraceptive vaginal ring (NuvaRing)
|
Oral Contraceptive Pill
n=137 Participants
Oral contraceptive pill (Ortho Tri-Cyclen Lo)
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.3 years
n=99 Participants
|
22 years
n=107 Participants
|
22.1 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
273 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
24 participants
n=99 Participants
|
20 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
66 participants
n=99 Participants
|
59 participants
n=107 Participants
|
125 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic African American
|
23 participants
n=99 Participants
|
28 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic other/multiple
|
10 participants
n=99 Participants
|
14 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Living arrangement
Alone
|
35 participants
n=99 Participants
|
32 participants
n=107 Participants
|
67 participants
n=206 Participants
|
|
Living arrangement
With partner
|
16 participants
n=99 Participants
|
11 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Living arrangement
With others, not partner
|
54 participants
n=99 Participants
|
63 participants
n=107 Participants
|
117 participants
n=206 Participants
|
|
Living arrangement
With family
|
30 participants
n=99 Participants
|
31 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Living arrangement
Missing
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Location
Dorm
|
29 participants
n=99 Participants
|
34 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Location
Off campus
|
106 participants
n=99 Participants
|
103 participants
n=107 Participants
|
209 participants
n=206 Participants
|
|
Location
Missing
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Religious preference
Catholic
|
33 participants
n=99 Participants
|
36 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Religious preference
Protestant
|
19 participants
n=99 Participants
|
22 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Religious preference
Baptist
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Religious preference
Other
|
18 participants
n=99 Participants
|
27 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Religious preference
None
|
54 participants
n=99 Participants
|
37 participants
n=107 Participants
|
91 participants
n=206 Participants
|
|
Religious preference
Missing
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Relationship status
Living with a partner in a committed relationship
|
19 participants
n=99 Participants
|
15 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Relationship status
A committed relationship, not living w/ a partner
|
60 participants
n=99 Participants
|
79 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Relationship status
Not in a committed relationship
|
57 participants
n=99 Participants
|
41 participants
n=107 Participants
|
98 participants
n=206 Participants
|
|
Relationship status
Missing
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Age at sexual debut
|
17.4 Years
n=99 Participants
|
17.8 Years
n=107 Participants
|
17.6 Years
n=206 Participants
|
|
Vaginal sex in the past month
Yes
|
100 participants
n=99 Participants
|
102 participants
n=107 Participants
|
202 participants
n=206 Participants
|
|
Vaginal sex in the past month
No
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Frequency of sex in current or most recent relationship
None
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Frequency of sex in current or most recent relationship
Once a month or less
|
15 participants
n=99 Participants
|
11 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Frequency of sex in current or most recent relationship
2 or 3 times a month
|
19 participants
n=99 Participants
|
18 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Frequency of sex in current or most recent relationship
Approximately once a week
|
25 participants
n=99 Participants
|
21 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Frequency of sex in current or most recent relationship
2 or 3 times a week
|
28 participants
n=99 Participants
|
37 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Frequency of sex in current or most recent relationship
More than 3 times a week
|
34 participants
n=99 Participants
|
36 participants
n=107 Participants
|
70 participants
n=206 Participants
|
|
Frequency of sex in current or most recent relationship
Missing
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Pregnant ever
Yes
|
24 participants
n=99 Participants
|
12 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Pregnant ever
No
|
101 participants
n=99 Participants
|
115 participants
n=107 Participants
|
216 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: For the first 3 months"Perfect use" was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles
Outcome measures
| Measure |
Contraceptive Vaginal Ring
n=136 Participants
Contraceptive vaginal ring (NuvaRing)
|
Oral Contraceptive Pill
n=137 Participants
Oral contraceptive pill (Ortho Tri-Cyclen Lo)
|
|---|---|---|
|
Adherence Rate (Rate of Perfect Method Use)
|
57 Percentage of Participants
|
45 Percentage of Participants
|
SECONDARY outcome
Timeframe: at 3 monthsPopulation: 26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)
Outcome measures
| Measure |
Contraceptive Vaginal Ring
n=121 Participants
Contraceptive vaginal ring (NuvaRing)
|
Oral Contraceptive Pill
n=126 Participants
Oral contraceptive pill (Ortho Tri-Cyclen Lo)
|
|---|---|---|
|
Satisfaction Rate
Satisfaction - Yes
|
68 Percentage of Participants
|
71 Percentage of Participants
|
|
Satisfaction Rate
Satisfaction - No
|
23 Percentage of Participants
|
25 Percentage of Participants
|
|
Satisfaction Rate
Missing
|
9 Percentage of Participants
|
4 Percentage of Participants
|
SECONDARY outcome
Timeframe: at 3 monthsPopulation: 26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)
Rate of intention to continue the contraceptive method at 3 months
Outcome measures
| Measure |
Contraceptive Vaginal Ring
n=121 Participants
Contraceptive vaginal ring (NuvaRing)
|
Oral Contraceptive Pill
n=126 Participants
Oral contraceptive pill (Ortho Tri-Cyclen Lo)
|
|---|---|---|
|
Continuation Rate
Continuation - Yes
|
43 Percentage of Participants
|
52 Percentage of Participants
|
|
Continuation Rate
Continuation - No
|
52 Percentage of Participants
|
48 Percentage of Participants
|
|
Continuation Rate
Missing
|
5 Percentage of Participants
|
0 Percentage of Participants
|
POST_HOC outcome
Timeframe: at 6 month (3 month after the end of the study period)Population: At 6 months, four from the contraceptive vaginal ring group and three from the oral contraceptive pill group did not complete the 6-month survey and thus were excluded from analysis.
Rate of intention to continue the contraceptive method at 6 months
Outcome measures
| Measure |
Contraceptive Vaginal Ring
n=117 Participants
Contraceptive vaginal ring (NuvaRing)
|
Oral Contraceptive Pill
n=123 Participants
Oral contraceptive pill (Ortho Tri-Cyclen Lo)
|
|---|---|---|
|
Continuation Rate
Continuation - Yes
|
26 Percentage of Participants
|
29 Percentage of Participants
|
|
Continuation Rate
Continuation - No
|
72 Percentage of Participants
|
68 Percentage of Participants
|
|
Continuation Rate
Missing
|
2 Percentage of Participants
|
2 Percentage of Participants
|
Adverse Events
Contraceptive Vaginal Ring
Serious events: 0 serious events
Other events: 100 other events
Deaths: 0 deaths
Oral Contraceptive Pill
Serious events: 0 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Contraceptive Vaginal Ring
n=136 participants at risk
Contraceptive vaginal ring (NuvaRing)
|
Oral Contraceptive Pill
n=137 participants at risk
Oral contraceptive pill (Ortho Tri-Cyclen Lo)
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
53.7%
73/136 • 6 months
|
56.9%
78/137 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
61.0%
83/136 • 6 months
|
50.4%
69/137 • 6 months
|
|
Investigations
Weight gain
|
11.8%
16/136 • 6 months
|
13.1%
18/137 • 6 months
|
|
Nervous system disorders
Headaches
|
68.4%
93/136 • 6 months
|
74.5%
102/137 • 6 months
|
|
Reproductive system and breast disorders
Breast swelling
|
52.2%
71/136 • 6 months
|
59.9%
82/137 • 6 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
10.3%
14/136 • 6 months
|
8.0%
11/137 • 6 months
|
|
Reproductive system and breast disorders
Vaginal discomfort
|
55.1%
75/136 • 6 months
|
42.3%
58/137 • 6 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
33.8%
46/136 • 6 months
|
10.9%
15/137 • 6 months
|
Additional Information
Melissa Gilliam
Department of Obstetrics and Gynecology, The University of Chicago
Phone: 773-834-0840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place