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Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

NCT02456584 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-10-18

No results posted yet for this study

Summary

This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

Conditions

  • Contraception

Interventions

DRUG

DMPA 150

injectable contraceptive

DRUG

DMPA 300

injectable contraceptive

DRUG

DMPA 104

injectable contraceptive

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • Asociación Dominicana Pro Bienestar de la Familia, Inc.

    collaborator OTHER

  • FHI 360

    lead OTHER

Principal Investigators

  • Vera Halpern, MD · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-08-30
Completion
2018-08-30
FDA Drug
Yes

Countries

  • United States
  • Dominican Republic

Study Locations

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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 NCT02456584 on ClinicalTrials.gov