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OpenTrials
Completed

NCT Number: NCT01299116

Long-Acting Reversible Contraception

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.

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Key information

Conditions

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Planned Parenthood Central North Carolina

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DMPA

Drug

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®.

oral contraceptives

Drug

Oral contraceptives (any variety of formulations are permitted)

Implanon®

Drug

Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)

Other names: Nexplanon®

ParaGard®

Drug

Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)

Mirena®

Drug

Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)

Primary outcomes

  1. Contraceptive Method Discontinuation

    Time frame: 24 months

Secondary outcomes

  1. Unintended Pregnancy

    Time frame: 24 months

    Intent-to-treat principles applied.

  2. Participant Attitudes to LARC vs SARC

    Time frame: 24 months

    Level of happiness with initial method (% distribution)

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Registry information

Official study title

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

Acronym: LARC

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2011
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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