Completed

LARCLong-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy

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What is being tested

DMPA

+ oral contraceptives

+ Implanon®

Drug
Who is being recruted

From 18 to 29 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: December 2011
See protocol details

Summary

Principal SponsorFHI 360
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2011

Actual date on which the first participant was enrolled.

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.

Official TitleLong-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy
NCT01299116
Principal SponsorFHI 360
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

916 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 29 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
18 to 29 years of age;
sexually active;
seeking oral or injectable contraception;
working cell phone;
Show More Criteria
3 exclusion criteria prevent from participating
currently pregnant;
previous use of a long-acting reversible contraceptive (LARC) method; and,
medical contraindications for oral contraceptives and injectables.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Participants received one of a variety of oral contraceptives or DMPA

Group II

Active Comparator
Participants received one of a variety of oral contraceptives or DMPA

Group III

Experimental
Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena®

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Planned Parenthood Central North Carolina

Chapel Hill, United StatesOpen Planned Parenthood Central North Carolina in Google Maps
CompletedOne Study Center