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Completed

NCT Number: NCT04682353

A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age

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.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 18001, Santo Domingo, Dominican Republic

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • used any of the following medications within 1 month prior to enrollment:
  • any investigational drug
  • oral contraceptives, contraceptive ring or patch
  • levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
  • is participating in another clinical trial
  • is pregnant
  • desires to become pregnant in subsequent 24 months
  • has been pregnant in last 3 months
  • is currently lactating

NOTE- Additional criteria apply, please contact the investigator for more information.

Treatment and study plan

TV-46046

Drug

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

Depo-subQ Provera

Drug

SC injection of 104 mg/0.65 mL

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)

    Time frame: Day 0 to Day 365

  2. Time to Reach Cmax (Tmax) of MPA

    Time frame: Day 0 to Day 365

  3. Serum MPA Concentration at Day 91 (C91)

    Time frame: Day 91

  4. Serum MPA Concentration at Day 182 (C182)

    Time frame: Day 182

  5. Serum MPA Concentration at Day 210 (C210)

    Time frame: Day 210

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

    Time frame: Day 0 to Day 182

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

    Time frame: Day 0 to Day 210

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

    Time frame: Day 0 to Day 365

  9. Apparent Terminal Half-life (t½) of MPA

    Time frame: Day 0 to Day 365

Secondary outcomes

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

    Time frame: Day 0 up to Week 78

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

    Time frame: Day 0 up to Week 78

    Concomitant medications included acetic acid derivatives and substances, aminoalkyl ethers, anilides, calcium compounds, other viral vaccines, and propionic acid derivatives etc.

  3. Number of Participants With Clinically Significant Changes in Vital Signs

    Time frame: Day 0 to Day 365

    Vital signs examination included blood pressure, respiration rate, pulse, and body temperature.

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

    Time frame: Day 7 and Weeks 13, 26, and 52

  5. Number of Participants With Overall Opinion of Vaginal Bleeding Pattern

    Time frame: Weeks 13, 26, and 52

    Number of participants with overall opinion of vaginal bleeding pattern as acceptable or not acceptable has been reported.

  6. Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores

    Time frame: Baseline, Weeks 4, 13, 26, and 52

    The PHQ-9 is a participant-rated depressive symptom severity scale to monitor severity over time for newly diagnosed participants or participants in current treatment for depression. Scoring was based on participants' responses to each of the 9 questions, as follows: 0=not at all; 1=several days; 2=more than half the days; and 3=nearly every day. The PHQ-9 total score was calculated as the sum of the 9 individual item scores. The PHQ-9 total score was categorized as follows: 0 = no depression, 1 to 4=minimal depression, 5 to 9=mild depression, 10 to 14=moderate depression, 15 to 19=moderately severe depression; and 20 to 27=severe depression. Higher scores indicate more severe depression.

  7. Number of Participants With Clinically Significant Changes in Liver Function Tests

    Time frame: Day 0 to Day 365

  8. Estradiol Concentrations

    Time frame: Baseline, Weeks 4, 13, 26, 30, and 52

  9. Number of Participants With No Ovulation in 12 Months

    Time frame: 12 months

    Ovulation was defined as one or more progesterone measurements ≥ 4.7 ng/mL in Weeks 48, 49, 50, 51 or 52.

  10. Number of Participants With 1 or More Injection Site Reactions (ISRs)

    Time frame: Day 0 to Day 365

    The ISRs included erythema, swelling, pruritus, bleeding, tenderness, bruising, hypopigmentation, atrophy, and injection site pain.

  11. Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)

    Time frame: Weeks 26 and 52

    Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.

  12. Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)

    Time frame: Weeks 26 and 52

    Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.

  13. Number of Participants With Responses to the Acceptability Question (If You Were at Risk for Pregnancy, Would You Use This Method of Contraception Outside of This Study?)

    Time frame: Weeks 26 and 52

    Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.

  14. Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)

    Time frame: Weeks 26 and 52

    Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.

  15. Progesterone Concentration

    Time frame: Weeks 48, 49, 50, 51, and 52

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Collaborators

  • FHI 360

Registry information

Official study title

A Randomized, Dose-range Finding Study to Evaluate Pharmacokinetics of Medroxyprogesterone Acetate Following a Single Subcutaneous Administration of TV-46046 in Healthy Women of Reproductive Age

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 23, 2020
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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