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
  Purpose

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 Intervention Phase
Contraception
Drug: DMPA
Drug: oral contraceptives
Drug: Implanon®
Drug: ParaGard®
Drug: Mirena®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Contraceptive method discontinuation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Unintended pregnancy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participant attitudes to LARC vs SARC [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 900
Study Start Date: December 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)
Active Comparator: 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01299116     History of Changes
Other Study ID Numbers: 10250
Study First Received: February 16, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by FHI 360:
AE adverse event
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
ICH International Conference of 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

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
3-keto-desogestrel
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 11, 2014