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Long-Acting Reversible Contraception (LARC)

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ClinicalTrials.gov Identifier: NCT01299116
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : January 26, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
FHI 360

Tracking Information
First Submitted Date  ICMJE February 16, 2011
First Posted Date  ICMJE February 18, 2011
Results First Submitted Date  ICMJE November 14, 2017
Results First Posted Date  ICMJE January 26, 2018
Last Update Posted Date February 28, 2018
Actual Study Start Date  ICMJE December 2011
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
Contraceptive Method Discontinuation [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
Contraceptive Method Discontinuation [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • Unintended Pregnancy [ Time Frame: 24 months ]
    Intent-to-treat principles applied.
  • Participant Attitudes to LARC vs SARC [ Time Frame: 24 months ]
    Level of happiness with initial method (% distribution)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
Measure attitudes [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Acting Reversible Contraception
Official Title  ICMJE Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Partially randomized patient preference trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • 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)
  • Drug: Implanon®
    Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)
    Other Name: 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)
Study Arms  ICMJE
  • Preference SARC
    Participants received one of a variety of oral contraceptives or DMPA
    Interventions:
    • Drug: DMPA
    • Drug: oral contraceptives
  • Experimental: Randomized LARC

    Participants receive one of the following interventions:

    Implanon® or Nexplanon®; ParaGard®; Mirena®

    Interventions:
    • Drug: Implanon®
    • Drug: ParaGard®
    • Drug: Mirena®
  • Active Comparator: Randomized SARC
    Participants received one of a variety of oral contraceptives or DMPA
    Interventions:
    • Drug: DMPA
    • Drug: oral contraceptives
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2016)
916
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2011)
900
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01299116
Other Study ID Numbers  ICMJE 10250
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party FHI 360
Study Sponsor  ICMJE FHI 360
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Hubacher, PhD FHI 360
PRS Account FHI 360
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP