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PK of Depo SubQ Injected in the Upper Arm

NCT ID: NCT01143207

Last Updated: 2013-08-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm

Conditions

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Contraception

Keywords

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AE adverse event DCF data collection forms DMC Data Monitoring Committee FDA U.S.) Food and Drug Administration GCP Good Clinical Practice guidelines ICH International Conference of Harmonisation IND Investigational New Drug Application IRB Institutional Review Board IU International units mg milligram(s) SAE serious adverse event µg microgram ULN upper limit of the normal range

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Medroxyprogesterone acetate

Single injection of Medroxyprogesterone acetate (hormonal contraceptive)

Group Type EXPERIMENTAL

Medroxyprogesterone acetate

Intervention Type DRUG

Injectable hormonal contraceptive

Interventions

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Medroxyprogesterone acetate

Injectable hormonal contraceptive

Intervention Type DRUG

Other Intervention Names

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Depo-SubQ Provera 104

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eastern Virginia Medical School

OTHER

Sponsor Role collaborator

FHI 360

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Archer, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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10206

Identifier Type: -

Identifier Source: org_study_id