N/A
Completed N=132
Study of Self or Clinic Administration of DepoProvera
Source: ClinicalTrials.gov NCT01019369 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Number of Participants Continuing DMPA at 6 Months — 61; 29 participants
Summary
Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Continuing DMPA at 6 Months |
61; 29 | — |
| SECONDARY Number of Participants Continuing DMPA |
61; 29 | — |
| SECONDARY Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available |
— | — |
| SECONDARY Prevalence of Participants With Persistent Skin Changes |
— | — |
| SECONDARY Scaled Satisfaction Score |
— | — |
| SECONDARY Average Minutes Spent Getting Ready for and Giving the Injection |
— | — |
Eligibility Criteria
Inclusion Criteria
- age greater than or equal to 18 years
- seeking DMPA for contraception
- English or Spanish speaking
- consistent access to a working telephone
- availability for follow up for one year
Exclusion Criteria
- suspected or continuing pregnancy
- undiagnosed vaginal bleeding
- known or suspected breast cancer
- acute liver disease
- known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
- desire for pregnancy within one year
Data sourced from ClinicalTrials.gov (NCT01019369). 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. Informational only — not medical advice.