NCT04682353

Brief Summary

The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The secondary objectives of the study are to evaluate and compare the safety, local tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The total duration of the study for each participant is expected to be up to 19.5 months.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2020

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

December 4, 2020

Results QC Date

July 11, 2023

Last Update Submit

July 11, 2023

Conditions

Contraception

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (9)

  • Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)

    Day 0 to Day 365

  • Time to Reach Cmax (Tmax) of MPA

    Day 0 to Day 365

  • Serum MPA Concentration at Day 91 (C91)

    Day 91

  • Serum MPA Concentration at Day 182 (C182)

    Day 182

  • Serum MPA Concentration at Day 210 (C210)

    Day 210

  • Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA

    Day 0 to Day 182

  • Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA

    Day 0 to Day 210

  • Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA

    Day 0 to Day 365

  • Apparent Terminal Half-life (t½) of MPA

    Day 0 to Day 365

Secondary Outcomes (15)

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Day 0 up to Week 78

  • Number of Participants With at Least 1 Concomitant Medication Use During Treatment

    Day 0 up to Week 78

  • Number of Participants With Clinically Significant Changes in Vital Signs

    Day 0 to Day 365

  • Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52

    Day 7 and Weeks 13, 26, and 52

  • Number of Participants With Overall Opinion of Vaginal Bleeding Pattern

    Weeks 13, 26, and 52

  • +10 more secondary outcomes

Study Arms (4)

Group 1 - 120 mg/0.4 mL

EXPERIMENTAL
Drug: TV-46046

Group 2 - 180 mg/0.6 mL

EXPERIMENTAL
Drug: TV-46046

Group 3 - 240 mg/0.8 mL

EXPERIMENTAL
Drug: TV-46046

Group 4 - 104 mg/0.65 mL

ACTIVE COMPARATOR
Drug: Depo-subQ Provera

Interventions

TV-46046DRUG

SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)

Group 1 - 120 mg/0.4 mLGroup 2 - 180 mg/0.6 mLGroup 3 - 240 mg/0.8 mL
Depo-subQ ProveraDRUG

SC injection of 104 mg/0.65 mL

Group 4 - 104 mg/0.65 mL

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • has regular menstrual cycle (21 to 35 days)
  • has a low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using nonhormonal intrauterine device (IUD), or consistently using barrier methods of contraception)
  • had a normal mammogram within the last year, if 40 years of age or older
  • NOTE- Additional criteria apply, please contact the investigator for more information.

You may not qualify if:

  • has multiple risk factors for cardiovascular disease (eg, smoking, obesity, hypertension, known low HDL, high LDL, or high triglyceride levels)
  • has current or history of ischemic heart disease
  • has active thrombophlebitis, current or past history of thromboembolic disorders, cerebral vascular disease or stroke
  • has systemic lupus erythematosus
  • has rheumatoid arthritis on immunosuppressive therapy
  • has unexplained vaginal bleeding
  • has diabetes
  • has strong family history of breast cancer (defined as one or more first degree relatives with breast cancer, breast cancer occurring before menopause in three or more family members, regardless of degree of relationship, and any male family member with breast cancer)
  • has current or history of breast cancer, or undiagnosed mass detected by breast exam
  • has current or history of cervical cancer
  • has cirrhosis or liver tumors
  • has known osteoporosis or osteopenia
  • has history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt, except short-lived situational depression that did not require medication and has not recurred in last five years
  • used MPA-containing injectable products in the past 12 months
  • used a combined injectable contraceptive in the past 6 months
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Teva Investigational Site 14002

Cypress, California, 90630, United States

Location

Teva Investigational Site 14003

San Antonio, Texas, 78209, United States

Location

Teva Investigational Site 18001

Santo Domingo, 99999, Dominican Republic

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Director, Clinical Research
Organization
Teva Branded Pharmaceutical Products, R&D Inc.
USMedInfo@tevapharm.com
888-483-8279

Study Officials

  • Teva Medical Expert, MD

    Teva Branded Pharmaceutical Products R&D, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 23, 2020

Study Start

December 14, 2020

Primary Completion

July 11, 2022

Study Completion

January 12, 2023

Last Updated

February 26, 2024

Results First Posted

February 26, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Upon primary clinical trial manuscript publication, researchers may request access to underlying study data. Each accepted article must be accompanied by a Data Availability Statement that describes where any primary data, associated metadata, original software, and any additional relevant materials necessary to understand, assess, and replicate the reported study findings in totality can be found. Underlying study data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Please email manuscript primary author to make your request.

Locations

US(2)DO(1)