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Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle

NCT02817464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-02-12

Study results available
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Summary

The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months.

Conditions

  • Pregnancy
  • Contraception

Interventions

DRUG

TV-46046 - 400 mg/mL

A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL

DRUG

TV-46046 - 200 mg/mL

A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/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
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-10-26
Primary Completion
2018-12-03
Completion
2018-12-03
FDA Drug
Yes

Countries

  • United States

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 NCT02817464 on ClinicalTrials.gov