Long-Acting Reversible Contraception (LARC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Contraceptive method discontinuation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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
|
|
Active Comparator: Implanon®
Contraception using subdermal contraceptive implant, marketed in the US as Implanon®
|
Drug: Contraception
|
|
Active Comparator: Mirena®
Contraception using intrauterine system, marketed in the US as Mirena®
|
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®.
|
Drug: Contraception
|
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 |
Inclusion Criteria:
- must be healthy
- must be between the ages of 18 and 29 years old
Exclusion Criteria:
-
Contacts and Locations| Contact: David Hubacher, PhD | 9195447040 ext 11223 | dhubacher@fhi.org |
| 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 | |
| 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: | March 27, 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 May 23, 2013