Long-Acting Reversible Contraception (LARC)

January 31, 2018 updated by: FHI 360

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

916

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Planned Parenthood Central North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Preference SARC
Participants received one of a variety of oral contraceptives or DMPA
Drug: DMPA
Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.
Drug: oral contraceptives
Oral contraceptives (any variety of formulations are permitted)
Experimental: Randomized LARC

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®
Drug: Implanon®
Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)
Other Names:
  • Nexplanon®
Drug: ParaGard®
Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)
Drug: Mirena®
Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)
Active Comparator: Randomized SARC
Participants received one of a variety of oral contraceptives or DMPA
Drug: DMPA
Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.
Drug: oral contraceptives
Oral contraceptives (any variety of formulations are permitted)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contraceptive Method Discontinuation
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unintended Pregnancy
Time Frame: 24 months
Intent-to-treat principles applied.
24 months
Participant Attitudes to LARC vs SARC
Time Frame: 24 months
Level of happiness with initial method (% distribution)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FHI 360

Investigators

  • Principal Investigator: David Hubacher, PhD, FHI 360

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10250 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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