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
  Purpose

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.


Condition Intervention Phase
Contraception
Drug: Contraception
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Contraceptive method discontinuation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure attitudes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ParaGard®
Intervention with long-acting reversible contraception (ParaGard®)
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: Implanon®
Contraception using subdermal contraceptive implant, marketed in the US as Implanon®
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: Mirena®
Contraception using intrauterine system, marketed in the US as Mirena®
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: 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®.
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®.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299116

Contacts
Contact: David Hubacher, PhD 9195447040 ext 11223 dhubacher@fhi.org

Locations
United States, North Carolina
Planned Parenthood Central North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Charles Monteith, MD    919-929-5402    charles.monteith@ppcentralnc.org   
Sponsors and Collaborators
FHI 360
Investigators
Principal Investigator: David Hubacher, PhD FHI 360
  More Information

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01299116     History of Changes
Other Study ID Numbers: 10250
Study First Received: February 16, 2011
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by FHI 360:
AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonisation
IND Investigational New Drug Application
IRB Institutional Review Board
IU International units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event
µg microgram
ULN upper limit of the normal range
WB Western Blot

Additional relevant MeSH terms:
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
3-keto-desogestrel
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014