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Long-Acting Reversible Contraception

Information source: FHI 360
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: DMPA (Drug); oral contraceptives (Drug); Implanon® (Drug); ParaGard® (Drug); Mirena® (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: FHI 360

Official(s) and/or principal investigator(s):
David Hubacher, PhD, Principal Investigator, Affiliation: FHI 360

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.

Clinical Details

Official title: Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Contraceptive method discontinuation

Unintended pregnancy

Secondary outcome: Participant attitudes to LARC vs SARC

Detailed description: In this partially randomized patient preference 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. It is expected that 38% of the participants using short-acting methods will stop using them during the first year and be at risk of unintended pregnancy. In contrast, less than 20% of LARC users will want to have their contraceptive removed. Continuation rates will be measured and pregnancies will be tallied in the two groups to document any differences that emerge.

Eligibility

Minimum age: 18 Years. Maximum age: 29 Years. Gender(s): Female.

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.

Locations and Contacts

Planned Parenthood Central North Carolina, Chapel Hill, North Carolina 27514, United States
Additional Information

Starting date: December 2011
Last updated: January 7, 2015

Page last updated: August 23, 2015

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