Long-Acting Reversible Contraception (LARC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01299116 |
Recruitment Status
:
Completed
First Posted
: February 18, 2011
Results First Posted
: January 26, 2018
Last Update Posted
: February 28, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contraception | Drug: DMPA Drug: oral contraceptives Drug: Implanon® Drug: ParaGard® Drug: Mirena® | Phase 4 |
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 |

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)
|
- Contraceptive Method Discontinuation [ Time Frame: 24 months ]
- Unintended Pregnancy [ Time Frame: 24 months ]Intent-to-treat principles applied.
- Participant Attitudes to LARC vs SARC [ Time Frame: 24 months ]Level of happiness with initial method (% distribution)

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 29 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, North Carolina | |
Planned Parenthood Central North Carolina | |
Chapel Hill, North Carolina, United States, 27514 |
Principal Investigator: | David Hubacher, PhD | FHI 360 |
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 |