Trial · NCT01019369
Study of Self or Clinic Administration of DepoProvera
NCT01019369, Not applicable, Completed, Carolyn L. Westhoff; results first posted 2015-04-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Self or Clinic Administration of DepoProvera. Trials, record NCT01019369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01019369
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Self or Clinic Administration of DepoProvera
- NCT number
- NCT01019369
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 132 participants, actual
- Lead sponsor
- Carolyn L. Westhoff
- Conditions
- Contraception
- Interventions
- Medroxyprogesterone 17-Acetate, Medroxyprogesterone 17-Acetate
- First posted
- 2009-11-25
- Last updated
- 2019-05-07
- Results first posted
- 2015-04-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Continuing DMPA at 6 Months | 6 months | 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 |
| Secondary | Number of Participants Continuing DMPA | 3, 9, 12 months | 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. |
| Secondary | Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available | 6, 12 months | The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA |
| Secondary | Prevalence of Participants With Persistent Skin Changes | 12 months | The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy) |
| Secondary | Scaled Satisfaction Score | 6, 12 months | This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires. |
| Secondary | Average Minutes Spent Getting Ready for and Giving the Injection | 0-12 months | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Continuing DMPA at 6 Months | 6 months | Data was analyzed with the assumption that participants who were lost to follow-up had discontinued DMPA use. | participants | NUMBER |
| SECONDARY | Number of Participants Continuing DMPA | 3, 9, 12 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available | 6, 12 months | Data were not collected. No analysis was performed. | ||
| SECONDARY | Prevalence of Participants With Persistent Skin Changes | 12 months | Data were not collected. No analysis was performed. | ||
| SECONDARY | Scaled Satisfaction Score | 6, 12 months | Data were not collected. No analysis was performed. | ||
| SECONDARY | Average Minutes Spent Getting Ready for and Giving the Injection | 0-12 months | Data were not collected. No analysis was performed. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Continuing DMPA at 6 Months | Self Administration of DMPA | 61 | participants | ||
| Number of Participants Continuing DMPA at 6 Months | Clinic Administration of DMPA | 29 | participants | ||
| Number of Participants Continuing DMPA | Self Administration of DMPA | 61 | Participants | ||
| Number of Participants Continuing DMPA | Clinic Administration of DMPA | 29 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Self Administration of DMPA | 86 | |
| Overall Study | STARTED | Clinic Administration of DMPA | 46 | |
| Overall Study | COMPLETED | Self Administration of DMPA | 76 | |
| Overall Study | COMPLETED | Clinic Administration of DMPA | 39 | |
| Overall Study | NOT COMPLETED | Self Administration of DMPA | 10 | |
| Overall Study | NOT COMPLETED | Clinic Administration of DMPA | 7 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Self Administration of DMPA | ||
| Total, all-cause mortality | Clinic Administration of DMPA | ||
| Total, other adverse events | Self Administration of DMPA | 0 | 86 |
| Total, other adverse events | Clinic Administration of DMPA | 0 | 46 |
| Total, serious adverse events | Self Administration of DMPA | 0 | 86 |
| Total, serious adverse events | Clinic Administration of DMPA | 0 | 46 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24656555 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Self Administration of DMPA vs Clinic Administration of DMPA: Number of Participants Continuing DMPA at 6 Months | Trial comparisons |
| Self Administration of DMPA vs Clinic Administration of DMPA: Number of Participants Continuing DMPA | Trial comparisons |
| Self Administration of DMPA vs Clinic Administration of DMPA: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01019369
GET https://conductscience.org/api/trials/v1/NCT01019369/registered