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Study of Self or Clinic Administration of DepoProvera

NCT01019369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2019-05-07

Study results available
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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.

Conditions

  • Contraception

Interventions

DRUG

Medroxyprogesterone 17-Acetate

Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year

DRUG

Medroxyprogesterone 17-Acetate

Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year

Sponsors & Collaborators

  • Family Planning Fellowship

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Carolyn L. Westhoff

    lead OTHER

Principal Investigators

  • Carolyn Westhoff, MD, MSc · Columbia University

  • Anitra Beasley, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-01-31
Completion
2012-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01019369 on ClinicalTrials.gov