Trial Outcomes & Findings for Study of Self or Clinic Administration of DepoProvera (NCT NCT01019369)
NCT ID: NCT01019369
Last Updated: 2019-05-07
Results Overview
The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA
COMPLETED
NA
132 participants
6 months
2019-05-07
Participant Flow
Participant milestones
| Measure |
Self Administration of DMPA
Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
Clinic Administration of DMPA
Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
46
|
|
Overall Study
COMPLETED
|
76
|
39
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Self Administration of DMPA
Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
Clinic Administration of DMPA
Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of Self or Clinic Administration of DepoProvera
Baseline characteristics by cohort
| Measure |
Self Administration of DMPA
n=86 Participants
Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
Clinic Administration of DMPA
n=46 Participants
Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
26.1 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
26.03 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=5 Participants
|
46 participants
n=7 Participants
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data was analyzed with the assumption that participants who were "lost to follow-up" had discontinued DMPA use.
The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA
Outcome measures
| Measure |
Self Administration of DMPA
n=86 Participants
Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
Clinic Administration of DMPA
n=45 Participants
Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
|---|---|---|
|
Number of Participants Continuing DMPA at 6 Months
|
61 participants
|
29 participants
|
SECONDARY outcome
Timeframe: 3, 9, 12 monthsPopulation: 115 women w 12 month follow-up data (76 and 39) . 10 participants LTFU in self-administration group, and 7 participants LTFU in the clinic administration group.
The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.
Outcome measures
| Measure |
Self Administration of DMPA
n=76 Participants
Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
Clinic Administration of DMPA
n=39 Participants
Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
|
|---|---|---|
|
Number of Participants Continuing DMPA
|
61 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6, 12 monthsPopulation: Data were not collected. No analysis was performed.
The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data were not collected. No analysis was performed.
The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6, 12 monthsPopulation: Data were not collected. No analysis was performed.
This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0-12 monthsPopulation: Data were not collected. No analysis was performed.
In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.
Outcome measures
Outcome data not reported
Adverse Events
Self Administration of DMPA
Clinic Administration of DMPA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place