Long-Acting Reversible Contraception

Phase 4

Completed

• Conditions: Contraception
• Interventions: Drug: Implanon®; Drug: DMPA; Drug: oral contraceptives; Drug: ParaGard®; Drug: Mirena®

• Registration Number: NCT01299116
• Lead Sponsor: FHI 360

Brief 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.

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.

Study Timeline

• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Study Start: 2011-12
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Results First Submitted: 2017-11-14
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-25
• Results First Posted: 2018-01-26
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 916

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized LARC	Mirena®	Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena®
Randomized LARC	Implanon®	Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena®
Randomized SARC	oral contraceptives	Participants received one of a variety of oral contraceptives or DMPA
Preference SARC	oral contraceptives	Participants received one of a variety of oral contraceptives or DMPA
Randomized LARC	ParaGard®	Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena®
Preference SARC	DMPA	Participants received one of a variety of oral contraceptives or DMPA
Randomized SARC	DMPA	Participants received one of a variety of oral contraceptives or DMPA

Primary Outcome Measures

Name	Time	Method
Contraceptive Method Discontinuation	24 months

Secondary Outcome Measures

Name	Time	Method
Participant Attitudes to LARC vs SARC	24 months	Level of happiness with initial method (% distribution)
Unintended Pregnancy	24 months	Intent-to-treat principles applied.

Trial Locations

Locations (1)

Planned Parenthood Central North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States