ContraceptionPhase 4NCT05505435
Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients
A Phase 4 study testing Depot-Medroxyprogestereone Acetate in people with Contraception, run by Northwestern University at 1 site in United States.
Trial summary
Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Depot-Medroxyprogestereone Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 30 Mar 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient planning DMPA for post-abortion contraception.
Who cannot join
- Patient cannot speak and read English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuation Rates of Self-administered Subcutaneous Depot Medroxyprogesterone Acetate and Provider-administered Intramuscular Depot Medroxyprogesterone Acetate in Patients Seeking Post-abortion Contraception
Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Thus far, studies investigating self-administered DMPA-SC have focused on patients presenting for contraception. Self-administered DMPA-SC has not been widely studied in patients seeking abortion and has been more extensively studied in international settings than in the US. The project will be a prospective cohort study of patients at a large, free-standing abortion clinic in Chicago, Illinois. Patients who indicate that they desire DMPA for post-abortion contraception will be recruited. They will choose either provider-administered DMPA-IM or self-administered DMPA-SC. Patients in both groups will complete a baseline survey that will collect demographic and clinical characteristics. Patients who choose self-administered DMPA-SC will receive self-injection teaching from study staff and will self-inject their first dose of DMPA-SC in the clinic. Patients who choose provider-administered DMPA-IM will receive their first dose of DMPA-IM in the clinic. Both groups will receive a prescription for three additional doses of DMPA and will receive an injection calendar. Study participants will receive a reminder prior to the start of the injection window for their second and third doses. After the injection window for the second and third doses closes, participants will complete follow up surveys. These surveys will assess whether patients received the subsequent doses of DMPA, reasons for discontinuing DMPA for patients who did not receive a dose, pregnancy status, and patient satisfaction with DMPA use. Follow up will be primarily via secure text messaging application with phone calls, email, and mail reserved for patients who cannot or prefer not to be contacted via text message. The primary outcome is continuation rates of DMPA-IM and DMPA-SC at 3 and 6 months after initiation. Secondary outcome measures include pregnancy, adverse effects, and patient satisfaction. We will also determine associations between patients' demographic and clinical characteristics and continuation of DMPA. This project will generate evidence that will support expanding access to DMPA-SC and providing patient education on self-injection, allowing for increased patient contraceptive autonomy.
- Conditions
- Contraception
- Being tested
- Depot-Medroxyprogestereone Acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot-Medroxyprogestereone AcetateDrug
subcutaneous depot medroxyprogesterone acetate
Depot-Medroxyprogestereone AcetateDrug
intramuscular depot medroxyprogesterone acetate
| Study group | Role | What they receive |
|---|---|---|
| DMPA-SC | Active comparator | self-administered subcutaneous depot medroxyprogesterone acetate 104 mg Receives: Drug: Depot-Medroxyprogestereone Acetate |
| DMPA-IM | Active comparator | provider-administered intramuscular depot medroxyprogesterone acetate 150 mg Receives: Drug: Depot-Medroxyprogestereone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
DMPA Continuation Rate
Continuation rates of DMPA-SC and DMPA-IM at 6 months via patient report
Measured: 6 months
Secondary outcomes (2)
DMPA Continuation Rate
Continuation rate of DMPA-SC and DMPA-IM at 3 months by patient report
Measured: 3 months
Patient Satisfaction and Ease of Use
Participants were given a study-bespoke questionnaire with 2 items each scored from 0 to 4 to gauge satisfaction and ease of use. Min score 0, max score 8 with higher scores indicating greater ease of use and satisfaction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Aug 2022
- Primary completion30 Sep 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505435
- Sponsor's protocol ID
- 00216775
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2022
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation Rates of Self-administered Subcutaneous Depot Medroxyprogesterone Acetate and Provider-administered Intramuscular Depot Medroxyprogesterone Acetate in Patients Seeking Post-abortion Contraception
- ClinicalTrials.gov ID
- NCT05505435
- Acronym / sponsor ID
- 00216775
- Conditions
- Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Thus far, studies investigating self-administered DMPA-SC have focused on patients presenting for contraception. Self-administered DMPA-SC has not been widely studied in patients seeking abortion and has been more extensively studied in international settings than in the US. The project will be a prospective cohort study of patients at a large, free-standing abortion clinic in Chicago, Illinois. Patients who indicate that they desire DMPA for post-abortion contraception will be recruited. They will choose either provider-administered DMPA-IM or self-administered DMPA-SC. Patients in both groups will complete a baseline survey that will collect demographic and clinical characteristics. Patients who choose self-administered DMPA-SC will receive self-injection teaching from study staff and will self-inject their first dose of DMPA-SC in the clinic. Patients who choose provider-administered DMPA-IM will receive their first dose of DMPA-IM in the clinic. Both groups will receive a prescription for three additional doses of DMPA and will receive an injection calendar. Study participants will receive a reminder prior to the start of the injection window for their second and third doses. After the injection window for the second and third doses closes, participants will complete follow up surveys. These surveys will assess whether patients received the subsequent doses of DMPA, reasons for discontinuing DMPA for patients who did not receive a dose, pregnancy status, and patient satisfaction with DMPA use. Follow up will be primarily via secure text messaging application with phone calls, email, and mail reserved for patients who cannot or prefer not to be contacted via text message. The primary outcome is continuation rates of DMPA-IM and DMPA-SC at 3 and 6 months after initiation. Secondary outcome measures include pregnancy, adverse effects, and patient satisfaction. We will also determine associations between patients' demographic and clinical characteristics and continuation of DMPA. This project will generate evidence that will support expanding access to DMPA-SC and providing patient education on self-injection, allowing for increased patient contraceptive autonomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMPA-SC | Active comparator | Drug: Depot-Medroxyprogestereone Acetateself-administered subcutaneous depot medroxyprogesterone acetate 104 mg |
| DMPA-IM | Active comparator | Drug: Depot-Medroxyprogestereone Acetateprovider-administered intramuscular depot medroxyprogesterone acetate 150 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient planning DMPA for post-abortion contraception.
Key exclusion criteria (1 listed)
- Patient cannot speak and read English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depot-Medroxyprogestereone Acetatesubcutaneous depot medroxyprogesterone acetate | Drug | DMPA-SC |
| Depot-Medroxyprogestereone Acetateintramuscular depot medroxyprogesterone acetate | Drug | DMPA-IM |
Primary outcome
DMPA Continuation Rate
Time frame: 6 months
Continuation rates of DMPA-SC and DMPA-IM at 6 months via patient report
2 secondary outcomes
DMPA Continuation Rate
Time frame: 3 months
Patient Satisfaction and Ease of Use
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Depot-Medroxyprogestereone Acetate in people with Contraception, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMPA Continuation Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.