Long-Acting Reversible Contraception

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Drug: DMPA
* Drug: oral contraceptives
* Drug: Implanon®
* Drug: ParaGard®
* Drug: Mirena®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Partially randomized patient preference trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Preference SARC<br>Participants received one of a variety of oral contraceptives or DMPA | Drug: DMPA<br>* 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®.<br>Drug: oral contraceptives<br>* Oral contraceptives (any variety of formulations are permitted)<br>|
| Experimental: Randomized LARC<br>Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena® | Drug: Implanon®<br>* Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)<br>* Other names: Nexplanon®;Drug: ParaGard®<br>* Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)<br>Drug: Mirena®<br>* Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)<br>|
| Active Comparator: Randomized SARC<br>Participants received one of a variety of oral contraceptives or DMPA | Drug: DMPA<br>* 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®.<br>Drug: oral contraceptives<br>* Oral contraceptives (any variety of formulations are permitted)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraceptive Method Discontinuation |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unintended Pregnancy | Intent-to-treat principles applied. | 24 months | 
| Participant Attitudes to LARC vs SARC | Level of happiness with initial method (% distribution) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AE-adverse event, FDA-(U.S.) Food and Drug Administration, GCP-Good Clinical Practice guidelines, ICH-International Committee on Harmonisation, IRB-Institutional Review Board, IU-International units, mg-milligram(s), mm3-cubic millimeter(s), LARC-Long-Acting reversible contraception, PPCNC-Planned Parenthood of North Carolina, SAE-serious adverse event, SARC-Short-Acting reversible contraception, µg-microgram, ULN-upper limit of the normal range, SubQ-subcutaneous