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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Contraception Drug: DMPA Drug: oral contraceptives Drug: Implanon® Drug: ParaGard® Drug: Mirena® Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 916 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Partially randomized patient preference trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy
Actual Study Start Date : December 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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 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: 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)


Outcome Measures
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Primary Outcome Measures :
  1. Contraceptive Method Discontinuation [ Time Frame: 24 months ]

Secondary Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299116


Locations
United States, North Carolina
Planned Parenthood Central North Carolina
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
FHI 360
Investigators
Principal Investigator: David Hubacher, PhD FHI 360
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01299116     History of Changes
Other Study ID Numbers: 10250
First Posted: February 18, 2011    Key Record Dates
Results First Posted: January 26, 2018
Last Update Posted: February 28, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by FHI 360:
AE-adverse event
FDA-(U.S.) Food and Drug Administration
GCP-Good Clinical Practice guidelines
ICH-International Committee on Harmonisation
IRB-Institutional Review Board
IU-International units
mg-milligram(s)
mm3-cubic millimeter(s)
 LARC-Long-Acting reversible contraception
PPCNC-Planned Parenthood of North Carolina
SAE-serious adverse event
SARC-Short-Acting reversible contraception
µg-microgram
ULN-upper limit of the normal range
SubQ-subcutaneous

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Etonogestrel
Contraceptives, Oral
 Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic