Long-Acting Reversible Contraception - Full Text View

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:

MedlinePlus related topics: Birth Control

Drug Information available for: Levonorgestrel Etonogestrel

U.S. FDA Resources

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:	January 7, 2015
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 Contraceptives, Oral Contraceptive Agents, Female Pharmacologic Actions	Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

Long-Acting Reversible Contraception (LARC)