Phase 4
N=894
Long-Acting Reversible Contraception
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01299116 ↗Enrolled (actual)
894
Serious AEs
0.1%
Results posted
Jan 2018
Primary outcome: Primary: Contraceptive Method Discontinuation — 300; 62; 142 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- DMPA (Drug); oral contraceptives (Drug); Implanon® (Drug); ParaGard® (Drug); Mirena® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- FHI 360
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contraceptive Method Discontinuation |
300; 62; 142 | — |
| SECONDARY Unintended Pregnancy |
47; 6; 13 | — |
| SECONDARY Participant Attitudes to LARC vs SARC |
354; 120; 138; 52; 15; 24 | — |
Summary
In the proposed study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24 month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method.
Eligibility Criteria
Inclusion Criteria
- 18 to 29 years of age;
- sexually active;
- seeking oral or injectable contraception;
- working cell phone;
- working email account;
- willingness to be contacted by the clinic staff or study coordinators; and,
- willingness to complete questionnaires.
Exclusion Criteria
- currently pregnant;
- previous use of a long-acting reversible contraceptive (LARC) method; and,
- medical contraindications for oral contraceptives and injectables.
Data sourced from ClinicalTrials.gov (NCT01299116). 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.