Contraception
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DRUGDMPA
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 (any variety of formulations are permitted)
DRUGImplanon®
Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)
DRUGParaGard®
Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)
DRUGMirena®
Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)
Sponsors
FHI 360
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Partially randomized patient preference trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contraceptive Method Discontinuation | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unintended Pregnancy | 24 months | Intent-to-treat principles applied. |
| Participant Attitudes to LARC vs SARC | 24 months | Level of happiness with initial method (% distribution) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 522 |
| 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) | 177 |
| 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) | 195 |
| Total | 894 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 65 | 9 | 11 |
Baseline characteristics
| Characteristic | Preference SARC | Randomized LARC | Randomized SARC | Total |
|---|---|---|---|---|
| Age, Continuous | 23 years | 23 years | 23 years | 23 years |
| Race/Ethnicity, Customized All other single and multiple race | 58 Participants | 18 Participants | 16 Participants | 92 Participants |
| Race/Ethnicity, Customized Hispanic | 68 Participants | 14 Participants | 30 Participants | 112 Participants |
| Race/Ethnicity, Customized Non-Hispanic, black | 124 Participants | 34 Participants | 44 Participants | 202 Participants |
| Race/Ethnicity, Customized Non-Hispanic, white | 269 Participants | 111 Participants | 105 Participants | 485 Participants |
| Sex: Female, Male Female | 522 Participants | 177 Participants | 195 Participants | 894 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 522 | 0 / 177 | 0 / 195 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 522 | 1 / 177 | 0 / 195 |
Outcome results
Primary
Contraceptive Method Discontinuation
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARC - Preference | Contraceptive Method Discontinuation | 300 Participants |
| LARC - Randomized | Contraceptive Method Discontinuation | 62 Participants |
| SARC - Randomized | Contraceptive Method Discontinuation | 142 Participants |
Secondary
Participant Attitudes to LARC vs SARC
Level of happiness with initial method (% distribution)
Time frame: 24 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARC - Preference | Participant Attitudes to LARC vs SARC | Happy | 354 Participants |
| SARC - Preference | Participant Attitudes to LARC vs SARC | Neutral | 52 Participants |
| SARC - Preference | Participant Attitudes to LARC vs SARC | Unhappy | 50 Participants |
| SARC - Preference | Participant Attitudes to LARC vs SARC | Missing | 66 Participants |
| LARC - Randomized | Participant Attitudes to LARC vs SARC | Missing | 9 Participants |
| LARC - Randomized | Participant Attitudes to LARC vs SARC | Happy | 120 Participants |
| LARC - Randomized | Participant Attitudes to LARC vs SARC | Unhappy | 33 Participants |
| LARC - Randomized | Participant Attitudes to LARC vs SARC | Neutral | 15 Participants |
| SARC - Randomized | Participant Attitudes to LARC vs SARC | Missing | 11 Participants |
| SARC - Randomized | Participant Attitudes to LARC vs SARC | Neutral | 24 Participants |
| SARC - Randomized | Participant Attitudes to LARC vs SARC | Unhappy | 22 Participants |
| SARC - Randomized | Participant Attitudes to LARC vs SARC | Happy | 138 Participants |
Secondary
Unintended Pregnancy
Intent-to-treat principles applied.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARC - Preference | Unintended Pregnancy | 47 Participants |
| LARC - Randomized | Unintended Pregnancy | 6 Participants |
| SARC - Randomized | Unintended Pregnancy | 13 Participants |