Long-Acting Reversible Contraception

Contraception Clinical Trial

— LARC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299116
• Other study ID #: 10250
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2011
• Last updated: January 31, 2018
• Start date: December 2011
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 916
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

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®.
• oral contraceptives
Oral contraceptives (any variety of formulations are permitted)
• Implanon®
Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)
• ParaGard®
Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)
• Mirena®
Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)

Locations

Country	Name	City	State
United States	Planned Parenthood Central North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
FHI 360

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hubacher D, Spector H, Monteith C, Chen PL, Hart C. Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial. Am J Obstet Gynecol. 2017 Feb;216(2):101-109. doi: 10.1016/j.ajog.2016.08.033. Epub 2016 Sep 20. — View Citation

Hubacher D, Spector H, Monteith C, Chen PL, Hart C. Rationale and enrollment results for a partially randomized patient preference trial to compare continuation rates of short-acting and long-acting reversible contraception. Contraception. 2015 Mar;91(3):185-92. doi: 10.1016/j.contraception.2014.11.006. Epub 2014 Nov 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive Method Discontinuation		24 months
Secondary	Unintended Pregnancy	Intent-to-treat principles applied.	24 months
Secondary	Participant Attitudes to LARC vs SARC	Level of happiness with initial method (% distribution)	24 months