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A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046

NCT03700658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-01-26

Study results available
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Summary

The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.

Conditions

  • Contraception

Interventions

DRUG

TV-46046

TV-46046 will be administered per dose and schedule specified in the arm.

DRUG

Depo-subQ 104

Depo-subQ 104 will be administered per dose and schedule specified in the arm.

DRUG

TV-46046 Placebo

TV-46046 Placebo will be administered per schedule specified in the arm.

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
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2020-10-02
Completion
2020-10-02
FDA Drug
Yes

Countries

  • 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 NCT03700658 on ClinicalTrials.gov