Long-Acting Reversible Contraception (LARC)

This study is currently recruiting participants.
Verified October 2013 by FHI 360
Sponsor:
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01299116
First received: February 16, 2011
Last updated: October 11, 2013
Last verified: October 2013

February 16, 2011
October 11, 2013
October 2011
December 2014   (final data collection date for primary outcome measure)
Contraceptive method discontinuation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01299116 on ClinicalTrials.gov Archive Site
Measure attitudes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Acting Reversible Contraception
Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy

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 12 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 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.

Unintended pregnancy remains a stubborn problem in the United States, particularly among younger women. Better access to long-acting reversible contraception (LARC) may help this population avoid unintended pregnancy and the dilemmas of considering abortion. The questions are whether LARC can be sufficiently desirable to use, and provide better protection from unintended pregnancy relative to the alternatives. Currently, many barriers prevent uptake of LARC, and thus a true measure of its potential is unknown. If LARC is found to be superior to other methods, more effort can be made to rejuvenate existing health programs and ensure that LARC is a guaranteed option for all those who want it.

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 12 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 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.

To assemble the proper evidence for fair comparisons, innovative strategies are needed. First, a hybrid intervention trial will be used to recruit two types of participants: those who have strong preferences for a particular method and those who would be willing to use a randomly assigned option. The randomized component and analysis will be used to isolate the contribution LARC can have in preventing unintended pregnancy. The cohort formed by choice of method will be used to document natural use patterns and provide comparative data. Participant attitudes toward LARC will identify barriers to more widespread uptake; a qualitative sub-study consisting of in-depth participant interviews will collect nuanced data on reasons for uptake and discontinuation of short and long-acting methods.

The evidence gathered from this study will help determine whether the perceived benefits of LARC can help alleviate the difficult problem of unintended pregnancy in the US. If so, the results will help stimulate progress toward that goal.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
Drug: Contraception
  • Intrauterine device marketed in the US as ParaGard®
  • Subdermal contraceptive implant, marketed in the US as Implanon®
  • Intrauterine system, marketed in the US as Mirena®
  • Oral contraceptives, containing 30 μg ethinyl estradiol and 0.15 mg levonorgestrel, marketed in the US as Levlen® (or its equivalent)OR 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®.
  • Active Comparator: ParaGard®
    Intervention with long-acting reversible contraception (ParaGard®)
    Intervention: Drug: Contraception
  • Active Comparator: Implanon®
    Contraception using subdermal contraceptive implant, marketed in the US as Implanon®
    Intervention: Drug: Contraception
  • Active Comparator: Mirena®
    Contraception using intrauterine system, marketed in the US as Mirena®
    Intervention: Drug: Contraception
  • Active Comparator: Levlen® OR Depo-Provera®
    Contraception using oral contraceptives, containing 30 μg ethinyl estradiol and 0.15 mg levonorgestrel, marketed in the US as Levlen® (or its equivalent) OR contraception using injectable 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®.
    Intervention: Drug: Contraception
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
June 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • must be healthy
  • must be between the ages of 18 and 29 years old

Exclusion Criteria:

-

Female
18 Years to 29 Years
Yes
Contact: David Hubacher, PhD 9195447040 ext 11223 dhubacher@fhi.org
United States
 
NCT01299116
10250
No
FHI 360
FHI 360
Not Provided
Principal Investigator: David Hubacher, PhD FHI 360
FHI 360
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP