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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04682353
Collaborator
FHI 360 (Other)
60
Enrollment
2
Locations
4
Arms
24.2
Anticipated Duration (Months)
30
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Dec 14, 2020
Anticipated Primary Completion Date :
Jul 6, 2022
Anticipated Study Completion Date :
Dec 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 - 120 mg/0.4 mL

Drug: TV-46046
SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)
Experimental: Group 2 - 180 mg/0.6 mL

Drug: TV-46046
SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)
Experimental: Group 3 - 240 mg/0.8 mL

Drug: TV-46046
SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)
Active Comparator: Group 4 - 104 mg/0.65 mL

Drug: DeposubQ Provera
SC injection of 104 mg/0.65 mL

Outcome Measures

Primary Outcome Measures

  1. Cmax (maximum observed serum concentration) [Day 0 to day 365]

  2. Tmax (time to Cmax) [Day 0 to day 365]

  3. Serum MPA concentrations [Day 91, 182, and 210]

  4. AUC (area under the serum drug concentration-time curve [Day 0 to Day 182, Day 0 to Day 210, Day 0 to ∞]

    AUC0-182 (area under the serum drug concentration-time curve from time 0 to day 182); AUC0-210 (AUC from time 0 to day 210); and AUC0-∞ (AUC extrapolated to infinity)

  5. Apparent terminal half-life (t½) [Day 0 to day 365]

Secondary Outcome Measures

  1. Occurrence of adverse events [Day 0 to day 365]

  2. Number of participants with clinically significant changes in vital signs including blood pressure, respiratory rate, body temperature, and pulse [Day 0 to day 365]

  3. Change in body weight [Day 0 to day 365]

  4. Number of participants reporting changes in vaginal bleeding pattern [Day 0 to day 365]

  5. Number of participants reporting a change in mood as measured using the score from the Patient Health Questionnaire (PHQ-9) [Day 0 to day 365]

    The Patient Health Questionnaire (PHQ-9) will be used to ascertain the frequency of a variety of somatic and emotional indicators of well-being and produce an overall score for the severity of depression. The minimum overall score is 0 and the maximum overall score for the PHQ-9 is 27. Higher values represent more severe depression status.

  6. Number of participants with changes in liver function tests [Day 0 to day 365]

  7. Change in estradiol (E2) levels [Day 0 to day 365]

  8. Number of participants reporting a delayed return to ovulation (>12 months after treatment initiation) where ovulation is defined as a single P≥4.7 ng/mL [Day 0 to day 365]

  9. Occurrence of injection site reactions (ISRs) [Day 0 to day 365]

  10. Responses to acceptablility questions [Week 26, Week 52]

    acceptability questions include likes and dislikes of the method and willingness to use the product in the future will be tabulated in frequency tables and compared between the test and the reference groups using descriptive Chi-squared tests.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Teva Investigational Site 14002 Cypress California United States 90630
2 Teva Investigational Site 14003 San Antonio Texas United States 78209

Sponsors and Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.
  • FHI 360

Investigators

  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier:
NCT04682353
Other Study ID Numbers:
  • TV46046-WH-10159
First Posted:
Dec 23, 2020
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.
Pharmacokinetics
Additional relevant MeSH terms:
Medroxyprogesterone Acetate
Medroxyprogesterone

Study Results

No Results Posted as of Jun 14, 2022