NCT01143207

Brief Summary

A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 19, 2013

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

1.4 years

First QC Date

June 7, 2010

Results QC Date

August 5, 2013

Last Update Submit

August 5, 2013

Conditions

Contraception

Keywords

AE adverse eventDCF data collection formsDMC Data Monitoring CommitteeFDA U.S.) Food and Drug AdministrationGCP Good Clinical Practice guidelinesICH International Conference of HarmonisationIND Investigational New Drug ApplicationIRB Institutional Review BoardIU International unitsmg milligram(s)SAE serious adverse eventµg microgramULN upper limit of the normal range

Outcome Measures

Primary Outcomes (6)

  • Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))

    120 days following injection

  • Tmax (Time to Cmax)

    120 days following injection

  • AUC 0-91 (Area Under Curve)

    first 91 days following injection

  • MPA Concentration at Day 91 (C91)

    day 91 after first injection

  • MPA Concentration at Day 104 (C104)

    day 104 after injection

  • MPA Concentration at Day 120 (C120)

    day 120 after injection

Study Arms (1)

Medroxyprogesterone acetate

EXPERIMENTAL

Single injection of Medroxyprogesterone acetate (hormonal contraceptive)

Drug: Medroxyprogesterone acetate

Interventions

Medroxyprogesterone acetateDRUG

Injectable hormonal contraceptive

Also known as: Depo-SubQ Provera 104
Medroxyprogesterone acetate

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40
  • negative pregnancy test on day of injection
  • not wishing to become pregnant in the next 12 months
  • at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD)
  • body mass index of 18-30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Vera Halpern, MD
Organization
FHI 360
vhalpern@fhi360.org
919-54-7040

Study Officials

  • David Archer, MD

    Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 14, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

August 19, 2013

Results First Posted

August 19, 2013

Record last verified: 2013-08

Locations

US(1)