Phase 4
Completed N=273
Acceptability of the NuvaRing Among Students
Birth Control Compliance
Source: ClinicalTrials.gov NCT00635570 ↗
Enrolled (actual)
273
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Adherence Rate (Rate of Perfect Method Use) — 57; 45 Percentage of Participants — p=0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence Rate (Rate of Perfect Method Use) |
57; 45 | 0.05 |
| SECONDARY Satisfaction Rate |
68; 71; 23; 25; 9; 4 | >0.05 |
| SECONDARY Continuation Rate |
26; 29; 72; 68; 2; 2 | >0.05 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00635570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.