CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
TV-46046 - 400 mg/mL +1 moredrug
Likely dose
TV-46046 400 mg/mL or 200 mg/mL as a single subcutaneous injection in the abdomenAI-extracted
Key inclusion· 5
  • ✓Regular menstrual cycle of 24 to 35 days
  • ✓At low risk of pregnancy (sterilized, same-sex partnership, monogamous with vasectomized partner, or non-hormonal IUD user)
  • ✓Good general health by medical history and physical examination
  • ✓Not pregnant and no desire to become pregnant in the subsequent 36 months
Key exclusion· 17
  • ✕Hypertension with systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg, or vascular disease
  • ✕Current or history of ischemic heart disease
  • ✕History of stroke or thromboembolic event
  • ✕Systemic lupus erythematosus with positive/unknown antiphospholipid antibodies or severe thrombocytopenia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02817464
NCT02817464Phase 1Completed
CompareCT.gov

A Two-part, Phase 1, Exploratory and Dose-range Finding Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following a Single Subcutaneous Administration of TV-46046 in Women With Ovulatory Cycle

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jun 29, 2016·Updated Feb 12, 2024

In Brief

A Phase 1 clinical trial evaluating TV-46046 - 400 mg/mL and TV-46046 - 200 mg/mL for Pregnancy and Contraception. Completed, enrolled 12 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Contraception
CountriesUnited States
CollaboratorsFHI 360

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 29, 2016
Enrollment StartOct 26, 2016
Primary CompletionDec 3, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.0 years ago

Interventions

TV-46046 - 400 mg/mLdrug

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

TV-46046 - 200 mg/mLdrug

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