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

June 2, 2023 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Teva Investigational Site 001
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Teva Investigational Site 002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • has regular menstrual cycle (24 to 35 days)
  • is at low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, in monogamous relationship with vasectomized partner, or using non-hormonal IUD)
  • is in good general health as determined by a medical history and physical examination
  • is not pregnant and does not have desire to become pregnant in the subsequent 36 months

  • has had a normal mammogram within the last year (for Part 1 only)

    • additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • has hypertension:

    • systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg
    • vascular disease
  • has current or history of ischemic heart disease
  • has history of stroke
  • has history of thromboembolic event

  • has systemic lupus erythematosus

    • positive (or unknown) antiphospholipid antibodies
    • severe thrombocytopenia
  • has rheumatoid arthritis on immunosuppressive therapy
  • has migraine with aura
  • has unexplained vaginal bleeding
  • has diabetes
  • has strong family history of breast cancer (defined as one or more first degree relatives, breast cancer occurring before menopause in three or more family members, regardless of degree of relationship, and any male family member with breast cancer), or current or history of breast cancer, or undiagnosed mass detected by breast exam
  • has current or history of cervical cancer
  • has severe cirrhosis (decompensated) or liver tumors
  • has known significant renal disease
  • used Depo-Provera Contraceptive Injection or Depo-subcutaneous Provera 104 (DMPA) products in the past 12 months

  • used any of the following medications within 1 month prior to enrollment:

    • any investigational drug
    • prohibited drugs per protocol
    • oral contraceptives, contraceptive ring or patch
    • levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
  • used a combined injectable contraceptive in the past 6 months
  • less than 3 months since the end of last pregnancy
  • currently lactating
  • is using or plans to use prohibited drugs per protocol in the next 18 months
  • has known sensitivity to MPA or inactive ingredients
  • has a plan to move to another location in the next 24 months

  • in the opinion of the investigator, potentially at elevated risk of HIV infection (eg, HIV -positive partner, IV drug use by self or by partner)

    • additional criteria apply, please contact the investigator for more information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TV-46046 - 1
Drug: TV-46046 - 400 mg/mL
A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL
Experimental: TV-46046 - 2
Drug: TV-46046 - 200 mg/mL
A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Serum MPA Concentration at Day 7
Time Frame: Day 7
Day 7
Part 1: Serum MPA Concentration at Day 28
Time Frame: Day 28
Day 28
Part 1: Serum MPA Concentration at Day 91
Time Frame: Day 91
Day 91
Part 1: Serum MPA Concentration at Day 182
Time Frame: Day 182
Day 182
Part 1: Serum MPA Concentration at Day 210
Time Frame: Day 210
Day 210
Part 1: Maximum Observed Serum Concentration (Cmax) of MPA
Time Frame: Day 0 up to Week 52
Day 0 up to Week 52
Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA
Time Frame: Day 182
Day 182
Part 1: Time to Reach Cmax (Tmax) of MPA
Time Frame: Day 0 up to Week 52
Day 0 up to Week 52
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
Time Frame: Day 0 up to Day 182
Day 0 up to Day 182
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
Time Frame: Day 0 up to Day 210
Day 0 up to Day 210
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA
Time Frame: Day 0 up to Week 52
Day 0 up to Week 52
Part 1: Apparent Terminal Half-life (t1/2) of MPA
Time Frame: Day 0 up to Week 52
Day 0 up to Week 52
Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1
Time Frame: Day 1
'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Day 1
Part 2: Time to Ovulation
Time Frame: Day 0 up to Week 78
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.
Day 0 up to Week 78

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1: Time to Ovulation
Time Frame: Day 0 up to Week 78
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. Time to ovulation was computed as the difference in days between detection of the first post-randomization elevated progesterone and the date of treatment initiation. Median time to ovulation was derived using Kaplan-Meier estimate.
Day 0 up to Week 78
Part 2: Cmax of MPA
Time Frame: Day 0 up to Week 52
Day 0 up to Week 52
Part 2: Tmax of MPA
Time Frame: Day 0 up to Week 52
Day 0 up to Week 52
Part 2: Observed Serum Drug Concentration at Day 210 (C210) of MPA
Time Frame: Day 0 up to Day 210
Day 0 up to Day 210
Part 2: C182 of MPA
Time Frame: Day 0 up to Day 182
Day 0 up to Day 182
Part 2: AUC0-182 of MPA
Time Frame: Day 0 up to Day 182
Day 0 up to Day 182
Part 2: AUC0-210 of MPA
Time Frame: Day 0 up to Day 210
Day 0 up to Day 210
Part 2: AUC0-∞ of MPA
Time Frame: Day 0 up to Week 52
Day 0 up to Week 52
Part 2: Apparent Terminal Half Life (t1/2) of MPA
Time Frame: Day 0 up to Week 52
Day 0 up to Week 52
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Day 0 up to Week 78
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Day 0 up to Week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FHI 360

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV46046-WH-10075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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