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Long-Acting Reversible Contraception

NCT01299116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 916

Last updated 2018-02-28

Study results available
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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.

Conditions

  • Contraception

Interventions

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)

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)

Sponsors & Collaborators

  • FHI 360

    lead OTHER

Principal Investigators

  • David Hubacher, PhD · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-06-30
Completion
2016-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01299116 on ClinicalTrials.gov