Phase 4 N=401 Randomized Health Services Research

Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT02509767 ↗

Enrolled (actual)

401

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms — 108; 85 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Subcutaneous depot medroxyprogesterone acetate (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Planned Parenthood Federation of America
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms	108; 85	—
SECONDARY Number of Participants Who Were Satisfied With Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in Both the Self- and Clinic Administration Arms	147; 137	—
SECONDARY Number of Participants Who Were Satisfied With Home Use of Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in the Self-Administration Arm	137	—
SECONDARY Costs Associated With Contraceptive Care	—	—

Summary

This randomized clinical trial will study subcutaneous depot medroxyprogesterone acetate (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient populations. Prior studies demonstrate that DMPA self-injection is safe, effective, feasible, and acceptable for women and adolescents. A total of 400 female patients (ages 15-44) requesting DMPA will be randomized to self-administration of DMPA sc or clinic administration (usual care). Subjects will be followed for one year. The primary study outcome is DMPA continuation at one year by self-report in both study arms. Secondary outcomes include patient-reported satisfaction with treatment; satisfaction with home use; and costs associated with contraceptive care. The investigators hypothesize higher continuation rates among self-injection users compared to patients who receive standard care. Secondary exploratory hypotheses include higher patient satisfaction and lower costs associated with contraceptive care among self-injection users.

Eligibility Criteria

Inclusion Criteria

Females ages 15-44
Current or past users of DMPA or desires initiation of DMPA for contraception
Can understand spoken and written English or Spanish
Willing to consider/attempt DMPA self-injection
Willing to be randomized to either self- or clinic administration of DMPA
Do not want to become pregnant in the next 12 months
Willing to provide contact information and to complete three surveys at baseline, 6 months, and 12 months
Have consistent access to a working telephone, email, and Internet
No contraindications to DMPA use

Exclusion Criteria

Suspected or confirmed pregnancy
Vaginal bleeding of unknown etiology
Known or suspected breast cancer
Acute liver disease
High blood pressure (Systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg)
Known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
Desire for pregnancy within one year

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02509767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.