NCT01019369

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 15, 2015

Completed
Last Updated

May 7, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

November 18, 2009

Results QC Date

December 4, 2014

Last Update Submit

April 16, 2019

Conditions

Contraception

Keywords

ContraceptionMedroxyprogesterone 17-acetateSelf administration

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Continuing DMPA at 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

    6 months

Secondary Outcomes (5)

  • Number of Participants Continuing DMPA

    3, 9, 12 months

  • Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available

    6, 12 months

  • Prevalence of Participants With Persistent Skin Changes

    12 months

  • Scaled Satisfaction Score

    6, 12 months

  • Average Minutes Spent Getting Ready for and Giving the Injection

    0-12 months

Study Arms (2)

Self Administration of DMPA

EXPERIMENTAL

Self administration of subcutaneous depot medroxyprogesterone acetate

Drug: Medroxyprogesterone 17-Acetate

Clinic administration of DMPA

ACTIVE COMPARATOR

Clinic administration (routine care) of DMPA

Drug: Medroxyprogesterone 17-Acetate

Interventions

Medroxyprogesterone 17-AcetateDRUG

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

Also known as: depo-subQ 104
Self Administration of DMPA

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

  • Beasley A, White KO, Cremers S, Westhoff C. Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate. Contraception. 2014 May;89(5):352-6. doi: 10.1016/j.contraception.2014.01.026. Epub 2014 Feb 7.

    PMID: 24656555DERIVED

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Anitra Beasley, MD, MPH
Organization
Baylor College of Medicine
anitra.beasley@bcm.edu
832-826-7318

Study Officials

  • Carolyn Westhoff, MD, MSc

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Anitra Beasley, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 25, 2009

Study Start

March 1, 2010

Primary Completion

January 1, 2011

Study Completion

November 1, 2012

Last Updated

May 7, 2019

Results First Posted

April 15, 2015

Record last verified: 2019-04

Locations

US(1)