Birth Control Compliance
Conditions
Keywords
Contraception, Compliance, Acceptability
Brief summary
The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.
Detailed description
For many women, college is a time of great change that affects one's social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois's Survey Research Laboratory, which examines women's attitudes and beliefs regarding various methods of birth control. The second part of the study is a comparison trial in which the women are randomized to either the NuvaRing ® vaginal contraceptive ring or a low dose oral contraceptive. The women are followed for three months to assess compliance, side effects, overall acceptability and intent to continue use of the method. Ultimately, we would like college women to be well informed about various methods of contraception available to them and to choose the contraceptive method that best suits their lifestyle.
Interventions
Low dose oral contraceptive
DEVICENuvaRing
Contraceptive vaginal ring
Sponsors
Organon
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* over 18 * student enrolled in college or graduate program * Not have used the contraceptive patch or oral contraceptives within the last month * Never have used a contraceptive vaginal ring * Interested in using hormonal contraceptives, specifically NuvaRing and oral contraceptive pills for next 3 months * In general good health * Premenopausal with the ability to menstruate
Exclusion criteria
* Known or suspected pregnancy * Pregnancy within 2 months of trial medication * Past use of any contraceptive vaginal ring * Hypersensitivity or allergy to NuvaRing or Oral Contraceptives * Use of investigational drug within 2 months of start of trial medication * Use of the contraceptive patch or oral contraceptives within past month * Use of any injectable contraception within 6 months of trial medication * Planning pregnancy in next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Rate (Rate of Perfect Method Use) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Rate | at 3 months | — |
| Continuation Rate | at 3 months | Rate of intention to continue the contraceptive method at 3 months |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
We screened 276 participants, of whom 273 were eligible because 3 of them did not meet inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Contraceptive Vaginal Ring Contraceptive vaginal ring (NuvaRing) | 136 |
| Oral Contraceptive Pill Oral contraceptive pill (Ortho Tri-Cyclen Lo) | 137 |
| Total | 273 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Did not complete survey | 2 | 1 |
| Overall Study | Early termination(No sexual activity) | 1 | 1 |
| Overall Study | Lost to Follow-up | 8 | 8 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Contraceptive Vaginal Ring | Oral Contraceptive Pill |
|---|---|---|---|
| Age at sexual debut | 17.6 Years | 17.4 Years | 17.8 Years |
| Age, Continuous | 22.1 years | 22.3 years | 22 years |
| Frequency of sex in current or most recent relationship 2 or 3 times a month | 37 participants | 19 participants | 18 participants |
| Frequency of sex in current or most recent relationship 2 or 3 times a week | 65 participants | 28 participants | 37 participants |
| Frequency of sex in current or most recent relationship Approximately once a week | 46 participants | 25 participants | 21 participants |
| Frequency of sex in current or most recent relationship Missing | 2 participants | 0 participants | 2 participants |
| Frequency of sex in current or most recent relationship More than 3 times a week | 70 participants | 34 participants | 36 participants |
| Frequency of sex in current or most recent relationship None | 6 participants | 4 participants | 2 participants |
| Frequency of sex in current or most recent relationship Once a month or less | 26 participants | 15 participants | 11 participants |
| Living arrangement Alone | 67 participants | 35 participants | 32 participants |
| Living arrangement Missing | 1 participants | 1 participants | 0 participants |
| Living arrangement With family | 61 participants | 30 participants | 31 participants |
| Living arrangement With others, not partner | 117 participants | 54 participants | 63 participants |
| Living arrangement With partner | 27 participants | 16 participants | 11 participants |
| Location Dorm | 63 participants | 29 participants | 34 participants |
| Location Missing | 1 participants | 1 participants | 0 participants |
| Location Off campus | 209 participants | 106 participants | 103 participants |
| Pregnant ever No | 216 participants | 101 participants | 115 participants |
| Pregnant ever Yes | 36 participants | 24 participants | 12 participants |
| Race/Ethnicity, Customized Hispanic | 44 participants | 24 participants | 20 participants |
| Race/Ethnicity, Customized Missing | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Non-Hispanic African American | 51 participants | 23 participants | 28 participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 28 participants | 13 participants | 15 participants |
| Race/Ethnicity, Customized Non-Hispanic other/multiple | 24 participants | 10 participants | 14 participants |
| Race/Ethnicity, Customized Non-Hispanic White | 125 participants | 66 participants | 59 participants |
| Relationship status A committed relationship, not living w/ a partner | 139 participants | 60 participants | 79 participants |
| Relationship status Living with a partner in a committed relationship | 34 participants | 19 participants | 15 participants |
| Relationship status Missing | 2 participants | 0 participants | 2 participants |
| Relationship status Not in a committed relationship | 98 participants | 57 participants | 41 participants |
| Religious preference Baptist | 24 participants | 11 participants | 13 participants |
| Religious preference Catholic | 69 participants | 33 participants | 36 participants |
| Religious preference Missing | 3 participants | 1 participants | 2 participants |
| Religious preference None | 91 participants | 54 participants | 37 participants |
| Religious preference Other | 45 participants | 18 participants | 27 participants |
| Religious preference Protestant | 41 participants | 19 participants | 22 participants |
| Sex: Female, Male Female | 273 Participants | 136 Participants | 137 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Vaginal sex in the past month No | 50 participants | 25 participants | 25 participants |
| Vaginal sex in the past month Yes | 202 participants | 100 participants | 102 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 100 / 136 | 105 / 137 |
| serious Total, serious adverse events | 0 / 136 | 0 / 137 |
Outcome results
Primary
Adherence Rate (Rate of Perfect Method Use)
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
Time frame: For the first 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contraceptive Vaginal Ring | Adherence Rate (Rate of Perfect Method Use) | 57 Percentage of Participants |
| Oral Contraceptive Pill | Adherence Rate (Rate of Perfect Method Use) | 45 Percentage of Participants |
Comparison: The trial sample size of 300 participants total (150 participants each group) was based on two-sided 5% significance testing with 80% power to detect a difference of 10% in adherence between students in the contraceptive vaginal ring group and oral contraceptive pill group.p-value: 0.05Chi-squared, Corrected
Secondary
Continuation Rate
Rate of intention to continue the contraceptive method at 3 months
Time frame: at 3 months
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contraceptive Vaginal Ring | Continuation Rate | Continuation - Yes | 43 Percentage of Participants |
| Contraceptive Vaginal Ring | Continuation Rate | Continuation - No | 52 Percentage of Participants |
| Contraceptive Vaginal Ring | Continuation Rate | Missing | 5 Percentage of Participants |
| Oral Contraceptive Pill | Continuation Rate | Continuation - Yes | 52 Percentage of Participants |
| Oral Contraceptive Pill | Continuation Rate | Continuation - No | 48 Percentage of Participants |
| Oral Contraceptive Pill | Continuation Rate | Missing | 0 Percentage of Participants |
p-value: >0.05Chi-squared, Corrected
Secondary
Satisfaction Rate
Time frame: at 3 months
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contraceptive Vaginal Ring | Satisfaction Rate | Satisfaction - Yes | 68 Percentage of Participants |
| Contraceptive Vaginal Ring | Satisfaction Rate | Satisfaction - No | 23 Percentage of Participants |
| Contraceptive Vaginal Ring | Satisfaction Rate | Missing | 9 Percentage of Participants |
| Oral Contraceptive Pill | Satisfaction Rate | Satisfaction - Yes | 71 Percentage of Participants |
| Oral Contraceptive Pill | Satisfaction Rate | Satisfaction - No | 25 Percentage of Participants |
| Oral Contraceptive Pill | Satisfaction Rate | Missing | 4 Percentage of Participants |
p-value: >0.05Chi-squared, Corrected
Post Hoc
Continuation Rate
Rate of intention to continue the contraceptive method at 6 months
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contraceptive Vaginal Ring | Continuation Rate | Continuation - Yes | 26 Percentage of Participants |
| Contraceptive Vaginal Ring | Continuation Rate | Continuation - No | 72 Percentage of Participants |
| Contraceptive Vaginal Ring | Continuation Rate | Missing | 2 Percentage of Participants |
| Oral Contraceptive Pill | Continuation Rate | Continuation - Yes | 29 Percentage of Participants |
| Oral Contraceptive Pill | Continuation Rate | Continuation - No | 68 Percentage of Participants |
| Oral Contraceptive Pill | Continuation Rate | Missing | 2 Percentage of Participants |
p-value: >0.05Chi-squared, Corrected