Trial Outcomes & Findings for Long-Acting Reversible Contraception (NCT NCT01299116)
NCT ID: NCT01299116
Last Updated: 2018-02-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
916 participants
Primary outcome timeframe
24 months
Results posted on
2018-02-28
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
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®.
|
|---|---|---|---|
|
Overall Study
STARTED
|
522
|
177
|
195
|
|
Overall Study
COMPLETED
|
457
|
168
|
184
|
|
Overall Study
NOT COMPLETED
|
65
|
9
|
11
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
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®.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
65
|
9
|
11
|
Baseline Characteristics
Long-Acting Reversible Contraception
Baseline characteristics by cohort
| Measure |
Preference SARC
n=522 Participants
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)
|
Randomized LARC
n=177 Participants
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)
|
Randomized SARC
n=195 Participants
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)
|
Total
n=894 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23 years
n=5 Participants
|
23 years
n=7 Participants
|
23 years
n=5 Participants
|
23 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
522 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
894 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
68 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, white
|
269 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
485 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, black
|
124 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
All other single and multiple race
|
58 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
SARC - Preference
n=522 Participants
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)
|
LARC - Randomized
n=177 Participants
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)
|
SARC - Randomized
n=195 Participants
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®.
|
|---|---|---|---|
|
Contraceptive Method Discontinuation
|
300 Participants
|
62 Participants
|
142 Participants
|
SECONDARY outcome
Timeframe: 24 monthsIntent-to-treat principles applied.
Outcome measures
| Measure |
SARC - Preference
n=466 Participants
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)
|
LARC - Randomized
n=168 Participants
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)
|
SARC - Randomized
n=187 Participants
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®.
|
|---|---|---|---|
|
Unintended Pregnancy
|
47 Participants
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 24 monthsLevel of happiness with initial method (% distribution)
Outcome measures
| Measure |
SARC - Preference
n=522 Participants
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)
|
LARC - Randomized
n=177 Participants
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)
|
SARC - Randomized
n=195 Participants
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®.
|
|---|---|---|---|
|
Participant Attitudes to LARC vs SARC
Happy
|
354 Participants
|
120 Participants
|
138 Participants
|
|
Participant Attitudes to LARC vs SARC
Neutral
|
52 Participants
|
15 Participants
|
24 Participants
|
|
Participant Attitudes to LARC vs SARC
Unhappy
|
50 Participants
|
33 Participants
|
22 Participants
|
|
Participant Attitudes to LARC vs SARC
Missing
|
66 Participants
|
9 Participants
|
11 Participants
|
Adverse Events
SARC - Preference
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LARC - Randomized
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
SARC - Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SARC - Preference
n=522 participants at risk
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)
|
LARC - Randomized
n=177 participants at risk
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)
|
SARC - Randomized
n=195 participants at risk
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®.
|
|---|---|---|---|
|
Reproductive system and breast disorders
endometritis
|
0.00%
0/522 • 24 months
Only serious adverse events were collected. AEs not captured.
|
0.56%
1/177 • Number of events 1 • 24 months
Only serious adverse events were collected. AEs not captured.
|
0.00%
0/195 • 24 months
Only serious adverse events were collected. AEs not captured.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place