A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
- Registration Number
- NCT04682353
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 - 120 mg/0.4 mL TV-46046 - Group 2 - 180 mg/0.6 mL TV-46046 - Group 4 - 104 mg/0.65 mL Depo-subQ Provera - Group 3 - 240 mg/0.8 mL TV-46046 -
- Primary Outcome Measures
Name Time Method 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 Apparent Terminal Half-life (t½) 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 Infinity (AUC0-inf) of MPA Day 0 to Day 365 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
- Secondary Outcome Measures
Name Time Method 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 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 Concomitant medications included acetic acid derivatives and substances, aminoalkyl ethers, anilides, calcium compounds, other viral vaccines, and propionic acid derivatives etc.
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?) Weeks 26 and 52 Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Estradiol Concentrations Baseline, Weeks 4, 13, 26, 30, and 52 Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?) Weeks 26 and 52 Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores 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.
Number of Participants With Clinically Significant Changes in Liver Function Tests Day 0 to Day 365 Number of Participants With 1 or More Injection Site Reactions (ISRs) Day 0 to Day 365 The ISRs included erythema, swelling, pruritus, bleeding, tenderness, bruising, hypopigmentation, atrophy, and injection site pain.
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?) Weeks 26 and 52 Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?) Weeks 26 and 52 Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Number of Participants With Clinically Significant Changes in Vital Signs Day 0 to Day 365 Vital signs examination included blood pressure, respiration rate, pulse, and body temperature.
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern Weeks 13, 26, and 52 Number of participants with overall opinion of vaginal bleeding pattern as acceptable or not acceptable has been reported.
Number of Participants With No Ovulation in 12 Months 12 months Ovulation was defined as one or more progesterone measurements ≥ 4.7 ng/mL in Weeks 48, 49, 50, 51 or 52.
Progesterone Concentration Weeks 48, 49, 50, 51, and 52
Trial Locations
- Locations (3)
Teva Investigational Site 14002
🇺🇸Cypress, California, United States
Teva Investigational Site 14003
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 18001
🇩🇴Santo Domingo, Dominican Republic