ACCEPT: Acceptability of the NuvaRing Among Students

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00635570
• Collaborator: Organon (Industry)
• Enrollment: 273
• Locations: 3
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 91
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Birth Control Compliance	Drug: Ortho Tri-cyclen Lo; Device: NuvaRing	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 273 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Acceptability of the NuvaRing Among College and Graduate Students
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Contraceptive vaginal ring Contraceptive vaginal ring (NuvaRing)	Device: NuvaRing; Contraceptive vaginal ring
Active Comparator: Oral contraceptive pill Oral contraceptive pill (Ortho Tri-cyclen Lo)	Drug: Ortho Tri-cyclen Lo; Low dose oral contraceptive

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Satisfaction Rate [at 3 months]

2. Continuation Rate [at 3 months]

   Rate of intention to continue the contraceptive method at 3 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago, Section of Family Planning	Chicago	Illinois	United States	60637
2	University of Chicago	Chicago	Illinois	United States	60637
3	University of Illinois	Chicago	Illinois	United States

Sponsors and Collaborators

• University of Chicago
• Organon

Investigators

• Principal Investigator: Melissa L Gilliam, MD, MPH, University of Chicago, Section of Family Planning

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Section of Family Planning web site

Publications

• Gilliam M, Holmquist S, Berlin A. Factors associated with willingness to use the contraceptive vaginal ring. Contraception. 2007 Jul;76(1):30-4. Epub 2007 May 24.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00635570
• Other Study ID Numbers: 14067B; NCT00145899
• First Posted: Mar 13, 2008
• Last Update Posted: Feb 3, 2021
• Last Verified: Jun 1, 2013

• Keywords provided by University of Chicago: Contraception, Compliance, Acceptability
• Additional relevant MeSH terms: Moxifloxacin; NuvaRing; Norgestimate, ethinyl estradiol drug combination

Study Results

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 Detail	We screened 276 participants, of whom 273 were eligible because 3 of them did not meet inclusion criteria.

Arm/Group Title	Contraceptive Vaginal Ring	Oral Contraceptive Pill
Arm/Group Description	Contraceptive vaginal ring (NuvaRing)	Oral contraceptive pill (Ortho Tri-Cyclen Lo)
Period Title: Overall Study
STARTED	136	137
COMPLETED	121	126
NOT COMPLETED	15	11

Baseline Characteristics

Arm/Group Title	Contraceptive Vaginal Ring	Oral Contraceptive Pill	Total
Arm/Group Description	Contraceptive vaginal ring (NuvaRing)	Oral contraceptive pill (Ortho Tri-Cyclen Lo)	Total of all reporting groups
Overall Participants	136	137	273
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	22.3	22	22.1
Sex: Female, Male (Count of Participants)
Female	136 100%	137 100%	273 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Hispanic	24 17.6%	20 14.6%	44 16.1%
Non-Hispanic White	66 48.5%	59 43.1%	125 45.8%
Non-Hispanic African American	23 16.9%	28 20.4%	51 18.7%
Non-Hispanic Asian	13 9.6%	15 10.9%	28 10.3%
Non-Hispanic other/multiple	10 7.4%	14 10.2%	24 8.8%
Missing	0 0%	1 0.7%	1 0.4%
Living arrangement (participants) [Number]
Alone	35 25.7%	32 23.4%	67 24.5%
With partner	16 11.8%	11 8%	27 9.9%
With others, not partner	54 39.7%	63 46%	117 42.9%
With family	30 22.1%	31 22.6%	61 22.3%
Missing	1 0.7%	0 0%	1 0.4%
Location (participants) [Number]
Dorm	29 21.3%	34 24.8%	63 23.1%
Off campus	106 77.9%	103 75.2%	209 76.6%
Missing	1 0.7%	0 0%	1 0.4%
Religious preference (participants) [Number]
Catholic	33 24.3%	36 26.3%	69 25.3%
Protestant	19 14%	22 16.1%	41 15%
Baptist	11 8.1%	13 9.5%	24 8.8%
Other	18 13.2%	27 19.7%	45 16.5%
None	54 39.7%	37 27%	91 33.3%
Missing	1 0.7%	2 1.5%	3 1.1%
Relationship status (participants) [Number]
Living with a partner in a committed relationship	19 14%	15 10.9%	34 12.5%
A committed relationship, not living w/ a partner	60 44.1%	79 57.7%	139 50.9%
Not in a committed relationship	57 41.9%	41 29.9%	98 35.9%
Missing	0 0%	2 1.5%	2 0.7%
Age at sexual debut (Years) [Median (Full Range) ]
Median (Full Range) [Years]	17.4	17.8	17.6
Vaginal sex in the past month (participants) [Number]
Yes	100 73.5%	102 74.5%	202 74%
No	25 18.4%	25 18.2%	50 18.3%
Frequency of sex in current or most recent relationship (participants) [Number]
None	4 2.9%	2 1.5%	6 2.2%
Once a month or less	15 11%	11 8%	26 9.5%
2 or 3 times a month	19 14%	18 13.1%	37 13.6%
Approximately once a week	25 18.4%	21 15.3%	46 16.8%
2 or 3 times a week	28 20.6%	37 27%	65 23.8%
More than 3 times a week	34 25%	36 26.3%	70 25.6%
Missing	0 0%	2 1.5%	2 0.7%
Pregnant ever (participants) [Number]
Yes	24 17.6%	12 8.8%	36 13.2%
No	101 74.3%	115 83.9%	216 79.1%

Outcome Measures

1. Primary Outcome

Title	Adherence Rate (Rate of Perfect Method Use)
Description	"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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contraceptive Vaginal Ring	Oral Contraceptive Pill
Arm/Group Description	Contraceptive vaginal ring (NuvaRing)	Oral contraceptive pill (Ortho Tri-Cyclen Lo)
Measure Participants	136	137
Number [Percentage of Participants]	57 41.9%	45 32.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Contraceptive Vaginal Ring, Oral Contraceptive Pill
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Chi-squared, Corrected
	Comments	Yates's chi-squared test with 1 degree of freedom was used for analysis

2. Secondary Outcome

Title	Satisfaction Rate
Time Frame	at 3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Contraceptive Vaginal Ring	Oral Contraceptive Pill
Arm/Group Description	Contraceptive vaginal ring (NuvaRing)	Oral contraceptive pill (Ortho Tri-Cyclen Lo)
Measure Participants	121	126
Satisfaction - Yes	68 50%	71 51.8%
Satisfaction - No	23 16.9%	25 18.2%
Missing	9 6.6%	4 2.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Contraceptive Vaginal Ring, Oral Contraceptive Pill
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared, Corrected
	Comments

3. Secondary Outcome

Title	Continuation Rate
Description	Rate of intention to continue the contraceptive method at 3 months
Time Frame	at 3 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Contraceptive Vaginal Ring	Oral Contraceptive Pill
Arm/Group Description	Contraceptive vaginal ring (NuvaRing)	Oral contraceptive pill (Ortho Tri-Cyclen Lo)
Measure Participants	121	126
Continuation - Yes	43 31.6%	52 38%
Continuation - No	52 38.2%	48 35%
Missing	5 3.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Contraceptive Vaginal Ring, Oral Contraceptive Pill
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared, Corrected
	Comments

4. Post-Hoc Outcome

Title	Continuation Rate
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Contraceptive Vaginal Ring	Oral Contraceptive Pill
Arm/Group Description	Contraceptive vaginal ring (NuvaRing)	Oral contraceptive pill (Ortho Tri-Cyclen Lo)
Measure Participants	117	123
Continuation - Yes	26 19.1%	29 21.2%
Continuation - No	72 52.9%	68 49.6%
Missing	2 1.5%	2 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Contraceptive Vaginal Ring, Oral Contraceptive Pill
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared, Corrected
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Contraceptive Vaginal Ring		Oral Contraceptive Pill
Arm/Group Description	Contraceptive vaginal ring (NuvaRing)		Oral contraceptive pill (Ortho Tri-Cyclen Lo)
All Cause Mortality
	Contraceptive Vaginal Ring		Oral Contraceptive Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Contraceptive Vaginal Ring		Oral Contraceptive Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/136 (0%)		0/137 (0%)
Other (Not Including Serious) Adverse Events
	Contraceptive Vaginal Ring		Oral Contraceptive Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	100/136 (73.5%)		105/137 (76.6%)
Gastrointestinal disorders
Bloating	73/136 (53.7%)		78/137 (56.9%)
Nausea	83/136 (61%)		69/137 (50.4%)
Investigations
Weight gain	16/136 (11.8%)		18/137 (13.1%)
Nervous system disorders
Headaches	93/136 (68.4%)		102/137 (74.5%)
Reproductive system and breast disorders
Breast swelling	71/136 (52.2%)		82/137 (59.9%)
Irregular menstruation	14/136 (10.3%)		11/137 (8%)
Vaginal discomfort	75/136 (55.1%)		58/137 (42.3%)
Vaginal discharge	46/136 (33.8%)		15/137 (10.9%)

Limitations/Caveats

This study is an randomized controlled trial offering internal but not necessarily external validity. Thus, we do not know whether these findings would be replicable in other populations.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.