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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preference SARC | Other | Participants received one of a variety of oral contraceptives or DMPA |
|
| Randomized LARC | Experimental | Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena® |
|
| Randomized SARC | Active Comparator | Participants received one of a variety of oral contraceptives or DMPA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMPA | Drug | 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®. |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Method Discontinuation | 24 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hubacher, PhD | FHI 360 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Central North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27662799 | Background | 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. | |
| 25500324 | Background |
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This is a partially randomized patient preference trial. Twenty two participants did not contribute data for analysis because they did not start a contraceptive in one of the three groups. For more information see: Hubacher D et al., 2017. The total number going forward for analysis is 894.
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| ID | Title | Description |
|---|---|---|
| FG000 | SARC - Preference | Participants received one of a variety of oral contraceptives or DMPA 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) |
| FG001 | LARC - Randomized | Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena® 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) |
| FG002 | SARC - Randomized | Participants received one of a variety of oral contraceptives or DMPA 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®. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preference SARC | Participants received one of a variety of oral contraceptives or DMPA 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Contraceptive Method Discontinuation | Posted | Count of Participants | Participants | 24 months |
|
24 months
Only serious adverse events were collected. AEs not captured.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SARC - Preference | Participants received one of a variety of oral contraceptives or DMPA 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| endometritis | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Hubacher | FHI 360 | 919 544 7040 | 11223 | dhubacher@fhi360.org |
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| ID | Term |
|---|---|
| C050795 | N,N-dimethyl-4-anisidine |
| D003276 | Contraceptives, Oral |
| C044815 | etonogestrel |
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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Partially randomized patient preference trial
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| oral contraceptives | Drug | Oral contraceptives (any variety of formulations are permitted) |
|
| Implanon® | Drug | Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel) |
|
|
| ParaGard® | Drug | Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface) |
|
| Mirena® | Drug | Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel) |
|
| 24 months |
| 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. |
| 29920171 | Derived | Burke HM, Packer CA, Spector HL, Hubacher D. Opportunity, satisfaction, and regret: Trying long-acting reversible contraception in a unique scientific circumstance. Women Health. 2019 Mar;59(3):266-280. doi: 10.1080/03630242.2018.1478363. Epub 2018 Aug 1. |
| 29470950 | Derived | Hubacher D, Spector H, Monteith C, Chen PL. Not seeking yet trying long-acting reversible contraception: a 24-month randomized trial on continuation, unintended pregnancy and satisfaction. Contraception. 2018 Jun;97(6):524-532. doi: 10.1016/j.contraception.2018.02.001. Epub 2018 Feb 19. |
| BG001 |
| Randomized LARC |
Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena® 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) |
| BG002 | Randomized SARC | Participants received one of a variety of oral contraceptives or DMPA 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) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Three participants did not provide race/ethnicity information | Count of Participants | Participants |
|
| OG002 | SARC - Randomized | Participants received one of a variety of oral contraceptives or DMPA 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®. |
|
|
| Secondary | Unintended Pregnancy | Intent-to-treat principles applied. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Participant Attitudes to LARC vs SARC | Level of happiness with initial method (% distribution) | Posted | Count of Participants | Participants | 24 months |
|
|
|
| 0 |
| 522 |
| 0 |
| 522 |
| 0 |
| 0 |
| EG001 | LARC - Randomized | Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena® 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) | 0 | 177 | 1 | 177 | 0 | 0 |
| EG002 | SARC - Randomized | Participants received one of a variety of oral contraceptives or DMPA 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®. | 0 | 195 | 0 | 195 | 0 | 0 |
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| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Unhappy |
|
| Missing |
|