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Long-Acting Reversible Contraception (LARC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01299116
First received: February 16, 2011
Last updated: May 19, 2014
Last verified: May 2014

February 16, 2011
May 19, 2014
December 2011
April 2016   (final data collection date for primary outcome measure)
  • Contraceptive method discontinuation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Unintended pregnancy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Contraceptive method discontinuation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01299116 on ClinicalTrials.gov Archive Site
Participant attitudes to LARC vs SARC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Measure attitudes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long-Acting Reversible Contraception
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
  • 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)
  • Active Comparator: SARC
    Participants received one of a variety of oral contraceptives or DMPA
    Interventions:
    • Drug: DMPA
    • Drug: oral contraceptives
  • Active Comparator: LARC

    Participants receive one of the following interventions:

    Implanon® or Nexplanon®; ParaGard®; Mirena®

    Interventions:
    • Drug: Implanon®
    • Drug: ParaGard®
    • Drug: Mirena®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
April 2016
April 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years to 29 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01299116
10250
No
FHI 360
FHI 360
Not Provided
Principal Investigator: David Hubacher, PhD FHI 360
FHI 360
May 2014

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