Long-Acting Reversible Contraception (LARC)

FHI 360

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Drug: Mirena®; Drug: DMPA; Drug: Implanon®; Drug: oral contraceptives; Drug: ParaGard®

Study type: Interventional

Funder types: Other

Identifiers

NCT01299116

10250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 916 patients

Sex: Female

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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916 participants in 3 patient groups

Preference SARC

Other group

Description:

Participants received one of a variety of oral contraceptives or DMPA

Treatment:

Drug: DMPA

Drug: oral contraceptives

Randomized LARC

Experimental group

Description:

Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena®

Treatment:

Drug: Mirena®

Drug: ParaGard®

Drug: Implanon®

Randomized SARC

Active Comparator group

Description:

Participants received one of a variety of oral contraceptives or DMPA

Treatment:

Drug: DMPA

Drug: oral contraceptives