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Lower Dose Depo Provera® Contraceptive Injection

NCT02732418 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-14

No results posted yet for this study

Summary

This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle

Conditions

  • Contraception

Interventions

DRUG

Depo-Provera CI

The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)

DRUG

Depo-subQ 104

The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA). Depo-subQ provera 104® (medroxyprogesterone acetate injectable suspension, 104 mg/0.65mL) for subcutaneous injection

Sponsors & Collaborators

  • FHI 360

    lead OTHER

Principal Investigators

  • Vera Halpern, MD · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-02
Primary Completion
2018-05-15
Completion
2018-05-15
FDA Drug
Yes

Countries

  • Brazil
  • Chile
  • 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 NCT02732418 on ClinicalTrials.gov