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A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age

NCT04682353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-26

Study results available
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Summary

The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants.

The secondary objectives of the study are to evaluate and compare the safety, local tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants.

The total duration of the study for each participant is expected to be up to 19.5 months.

Conditions

  • Contraception

Interventions

DRUG

TV-46046

SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)

DRUG

Depo-subQ Provera

SC injection of 104 mg/0.65 mL

Sponsors & Collaborators

  • FHI 360

    collaborator OTHER

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2022-07-11
Completion
2023-01-12
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 NCT04682353 on ClinicalTrials.gov