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Progestin

TV-46046 for Birth Control

Phase 1
Waitlist Available
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will compare the effects of 3 different doses of TV-46046 with Depo-subQ Provera in healthy female participants. The study will last up to 19.5 months for each participant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent Terminal Half-life (t½) of MPA
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
+6 more
Secondary outcome measures
Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
Estradiol Concentrations
Number of Participants With 1 or More Injection Site Reactions (ISRs)
+12 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 3 - 240 mg/0.8 mLExperimental Treatment1 Intervention
Group II: Group 2 - 180 mg/0.6 mLExperimental Treatment1 Intervention
Group III: Group 1 - 120 mg/0.4 mLExperimental Treatment1 Intervention
Group IV: Group 4 - 104 mg/0.65 mLActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TV-46046
2020
Completed Phase 1
~90

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
251 Previous Clinical Trials
3,485,316 Total Patients Enrolled
FHI 360OTHER
99 Previous Clinical Trials
301,300 Total Patients Enrolled
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,719 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this research endeavor?

"Those hoping to be admitted into this trial must have contraception and fall within the age range of 18-45. The team aims to recruit around 60 individuals for the study."

Answered by AI

What other experiments have evaluated the efficacy of TV-46046?

"TV-46046 was initially examined in the Women's Cancer Center of Nevada during 2015. 73 studies have been finished to date, with 10 still on-going primarily located in Cypress, California."

Answered by AI

What evidence is there to support the safety of TV-46046 for its recipients?

"We have limited information on the safety of TV-46046, so it was assigned a score of 1. This is due to being an early stage trial that has not generated much data regarding efficacy or safety."

Answered by AI

Is this trial actively seeking out participants?

"According to the information on clinicaltrials.gov, this research has ceased its recruitment of participants; it was initially posted in December 2020 and last updated November 2022. Despite that, there are still 71 other trials currently seeking out enrollees."

Answered by AI

Is this research novel in comparison to prior studies?

"As of now, 10 studies implementing TV-46046 have been initiated, taking place in 37 cities and 7 nations. The first trial for this drug was conducted by Novartis Pharmaceuticals all the way back in 2015; it encompassed 74 patients and finished its second stage of pharmaceutical approval. Since then, 73 more trials have concluded successfully."

Answered by AI

What medical symptoms is TV-46046 typically used to address?

"TV-46046 is typically prescribed to alleviate the hot flashes and night sweats associated with menopause. It also has applications for contraception, endometrial hyperplasia, and pain management."

Answered by AI

Does the age limitation on this trial extend past 30 years of age?

"This trial is seeking out participants within the age range of 18 and 45 years old."

Answered by AI

How many individuals have been recruited for this research project?

"This medical trial is no longer accepting candidates. It was first posted on December 14th 2020 and underwent its last update on November 18th 2022. Currently, 61 other trials are recruiting people who need contraception while 10 studies require enrollees for TV-46046 research."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
2020. "A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04682353.
~14 spots leftby Apr 2025
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