NCT01299116

Long-Acting Reversible Contraception

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 916 (actual)
• Sponsor: FHI 360 · Academic / Other
• Sex: Female
• Age: 18 Years – 29 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Contraception

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2011-12-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2011-02-18
• Last updated: 2018-02-28
• Results posted: 2018-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study