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CompletedNCT04682353Updated Feb 26, 2024Results posted

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

A Phase 1 interventional study of TV-46046 and Depo-subQ Provera in Contraception, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 3 sites in 2 countries. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Contraception

Keywords

  • Pharmacokinetics
03

In context

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Group 1 - 120 mg/0.4 mL

    Drug: TV-46046

  • Experimental
    Group 2 - 180 mg/0.6 mL

    Drug: TV-46046

  • Experimental
    Group 3 - 240 mg/0.8 mL

    Drug: TV-46046

  • Active comparator
    Group 4 - 104 mg/0.65 mL

    Drug: Depo-subQ Provera

Interventions

  • DrugTV-46046

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

  • DrugDepo-subQ Provera

    SC injection of 104 mg/0.65 mL

06

What researchers measure

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

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

    Time frame: Day 0 up to Week 78

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

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

    Time frame: Day 0 to Day 365

  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

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

    Time frame: Weeks 13, 26, and 52

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

    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.

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

  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

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

    Time frame: 12 months

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

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

    Time frame: Day 0 to Day 365

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

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

    Time frame: Weeks 26 and 52

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

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

    Time frame: Weeks 26 and 52

  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?)

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

    Time frame: Weeks 26 and 52

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

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

    Time frame: Weeks 26 and 52

  15. Progesterone Concentration

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

07

Results

Posted Feb 26, 2024

Participant flow

Participant flow — Overall Study
MilestoneTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Started16151415
Received at least 1 dose of study drug16151415
Completed16131414
Not completed0201
Withdrew: Lost to follow-up0101
Withdrew: Personal reasons0100

Outcome measures

PrimaryMaximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)
Time frame:
Day 0 to Day 365
Reported as:
Geometric mean · nanograms (ng)/ milliliter (mL)
Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)
nanograms (ng)/ milliliter (mL)TV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)0.940 ± 41.1871.180 ± 39.0761.750 ± 41.4070.963 ± 47.672
Statistical analysis
  • TV46046 Dose A vs Depo-subQ Provera · Geometric mean ratio: 0.976 · 90% CI 0.748 to 1.274
  • TV46046 Dose B vs Depo-subQ Provera · Geometric mean ratio: 1.226 · 90% CI 0.940 to 1.598
  • TV46046 Dose C vs Depo-subQ Provera · Geometric mean ratio: 1.817 · 90% CI 1.380 to 2.392
PrimaryTime to Reach Cmax (Tmax) of MPA
Time frame:
Day 0 to Day 365
Reported as:
Median · days
Time to Reach Cmax (Tmax) of MPA
daysTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Time to Reach Cmax (Tmax) of MPA17.0 (1.0 to 105.0)28.0 (1.0 to 71.0)6.0 (2.0 to 336.0)31.5 (1.0 to 105.0)
PrimarySerum MPA Concentration at Day 91 (C91)
Time frame:
Day 91
Reported as:
Geometric mean · ng/mL
Serum MPA Concentration at Day 91 (C91)
ng/mLTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Serum MPA Concentration at Day 91 (C91)0.570 ± 36.8020.660 ± 49.3601.090 ± 40.1510.474 ± 37.765
Statistical analysis
  • TV46046 Dose A vs Depo-subQ Provera · Geometric mean ratio: 1.202 · 90% CI 0.960 to 1.506
  • TV46046 Dose B vs Depo-subQ Provera · Geometric mean ratio: 1.393 · 90% CI 1.070 to 1.815
  • TV46046 Dose C vs Depo-subQ Provera · Geometric mean ratio: 2.301 · 90% CI 1.806 to 2.933
PrimarySerum MPA Concentration at Day 182 (C182)
Time frame:
Day 182
Reported as:
Geometric mean · ng/mL
Serum MPA Concentration at Day 182 (C182)
ng/mLTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Serum MPA Concentration at Day 182 (C182)0.201 ± 69.4290.279 ± 65.7930.443 ± 60.5310.118 ± 150.789
Statistical analysis
  • TV46046 Dose A vs Depo-subQ Provera · Geometric mean ratio: 1.699 · 90% CI 0.921 to 3.135
  • TV46046 Dose B vs Depo-subQ Provera · Geometric mean ratio: 2.364 · 90% CI 1.273 to 4.390
  • TV46046 Dose C vs Depo-subQ Provera · Geometric mean ratio: 3.748 · 90% CI 2.033 to 6.908
PrimarySerum MPA Concentration at Day 210 (C210)
Time frame:
Day 210
Reported as:
Geometric mean · ng/mL
Serum MPA Concentration at Day 210 (C210)
ng/mLTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Serum MPA Concentration at Day 210 (C210)0.119 ± 105.7270.208 ± 76.6830.365 ± 69.3570.063 ± 244.107
Statistical analysis
  • TV46046 Dose A vs Depo-subQ Provera · Geometric mean ratio: 1.904 · 90% CI 0.886 to 4.093
  • TV46046 Dose B vs Depo-subQ Provera · Geometric mean ratio: 3.317 · 90% CI 1.585 to 6.942
  • TV46046 Dose C vs Depo-subQ Provera · Geometric mean ratio: 5.824 · 90% CI 2.796 to 12.135
PrimaryArea Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
Time frame:
Day 0 to Day 182
Reported as:
Geometric mean · days*ng/mL
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
days*ng/mLTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA94.2 ± 27.0121.8 ± 38.1173.6 ± 25.886.1 ± 29.6
Statistical analysis
  • TV46046 Dose A vs Depo-subQ Provera · Geometric mean ratio: 1.095 · 90% CI 0.920 to 1.302
  • TV46046 Dose B vs Depo-subQ Provera · Geometric mean ratio: 1.415 · 90% CI 1.148 to 1.744
  • TV46046 Dose C vs Depo-subQ Provera · Geometric mean ratio: 2.017 · 90% CI 1.692 to 2.405
PrimaryArea Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
Time frame:
Day 0 to Day 210
Reported as:
Geometric mean · days*ng/mL
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
days*ng/mLTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA100.2 ± 23.9129.6 ± 37.8187.0 ± 26.090.1 ± 27.6
Statistical analysis
  • TV46046 Dose A vs Depo-subQ Provera · Geometric mean ratio: 1.112 · 90% CI 0.948 to 1.303
  • TV46046 Dose B vs Depo-subQ Provera · Geometric mean ratio: 1.439 · 90% CI 1.174 to 1.762
  • TV46046 Dose C vs Depo-subQ Provera · Geometric mean ratio: 2.075 · 90% CI 1.751 to 2.459
PrimaryArea Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA
Time frame:
Day 0 to Day 365
Reported as:
Geometric mean · days*ng/mL
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA
days*ng/mLTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA117.2 ± 17.9160.8 ± 36.6224.9 ± 18.9105.1 ± 19.5
Statistical analysis
  • TV46046 Dose A vs Depo-subQ Provera · Geometric mean ratio: 1.115 · 90% CI 0.993 to 1.252
  • TV46046 Dose B vs Depo-subQ Provera · Geometric mean ratio: 1.530 · 90% CI 1.277 to 1.833
  • TV46046 Dose C vs Depo-subQ Provera · Geometric mean ratio: 2.140 · 90% CI 1.888 to 2.425
PrimaryApparent Terminal Half-life (t½) of MPA
Time frame:
Day 0 to Day 365
Reported as:
Median · days
Apparent Terminal Half-life (t½) of MPA
daysTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Apparent Terminal Half-life (t½) of MPA47.4 (18.7 to 114.8)85.3 (15.7 to 160.2)79.8 (19.4 to 130.4)37.4 (8.2 to 224.3)
SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame:
Day 0 up to Week 78
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Number of Participants With Treatment-emergent Adverse Events (TEAEs)1110812
SecondaryNumber of Participants With at Least 1 Concomitant Medication Use During Treatment

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

Time frame:
Day 0 up to Week 78
Reported as:
Count of participants · Participants
Number of Participants With at Least 1 Concomitant Medication Use During Treatment
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Number of Participants With at Least 1 Concomitant Medication Use During Treatment118610
SecondaryNumber of Participants With Clinically Significant Changes in Vital Signs

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

Time frame:
Day 0 to Day 365
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes in Vital Signs
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Number of Participants With Clinically Significant Changes in Vital Signs0000
SecondaryChange From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
Time frame:
Day 7 and Weeks 13, 26, and 52
Reported as:
Mean · kilograms (kg)
Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
kilograms (kg)TV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Change at Day 7-0.21 ± 0.19-0.27 ± 0.20-0.33 ± 0.170.05 ± 0.28
Change at Week 13-1.10 ± 1.420.92 ± 0.650.84 ± 0.351.40 ± 0.87
Change at Week 261.14 ± 0.582.91 ± 1.111.38 ± 0.742.68 ± 0.89
Change at Week 520.60 ± 0.561.38 ± 1.000.79 ± 1.061.99 ± 0.91
SecondaryNumber of Participants With Overall Opinion of Vaginal Bleeding Pattern

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

Time frame:
Weeks 13, 26, and 52
Reported as:
Count of participants · Participants
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Week 13 — Acceptable1091111
Week 13 — Not Acceptable6534
Week 26 — Acceptable1213912
Week 26 — Not Acceptable4141
Week 52 — Acceptable14121313
Week 52 — Not Acceptable2111
SecondaryNumber of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores

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.

Time frame:
Baseline, Weeks 4, 13, 26, and 52
Reported as:
Count of participants · Participants
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Baseline — No Depression129109
Baseline — Minimal Depression4435
Baseline — Mild Depression0211
Baseline — Moderate Depression0000
Baseline — Moderately Severe Depression0000
Baseline — Severe Depression0000
Week 4 — No Depression91096
Week 4 — Minimal Depression5437
Week 4 — Mild Depression1111
Week 4 — Moderate Depression1001
Week 4 — Moderately Severe Depression0010
Week 4 — Severe Depression0000
Week 13 — No Depression8699
Week 13 — Minimal Depression6754
Week 13 — Mild Depression2201
Week 13 — Moderate Depression0001
Week 13 — Moderately Severe Depression0000
Week 13 — Severe Depression0000
Week 26 — No Depression1071010
Week 26 — Minimal Depression4522
Week 26 — Mild Depression2211
Week 26 — Moderate Depression0000
Week 26 — Moderately Severe Depression0000
Week 26 — Severe Depression0000
Week 52 — No Depression1161012
Week 52 — Minimal Depression4532
Week 52 — Mild Depression1100
Week 52 — Moderate Depression0100
Week 52 — Moderately Severe Depression0010
Week 52 — Severe Depression0000
SecondaryNumber of Participants With Clinically Significant Changes in Liver Function Tests
Time frame:
Day 0 to Day 365
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes in Liver Function Tests
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Number of Participants With Clinically Significant Changes in Liver Function Tests0000
SecondaryEstradiol Concentrations
Time frame:
Baseline, Weeks 4, 13, 26, 30, and 52
Reported as:
Mean · picograms (pg)/mL
Estradiol Concentrations
picograms (pg)/mLTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Baseline64.988 ± 57.16952.825 ± 22.85763.962 ± 74.81566.181 ± 64.843
Week 472.357 ± 38.85549.027 ± 48.37331.149 ± 13.39455.699 ± 28.077
Week 1362.389 ± 56.31645.890 ± 30.47536.337 ± 25.06542.071 ± 30.137
Week 26114.347 ± 67.997177.369 ± 197.66152.132 ± 38.971105.234 ± 67.421
Week 30133.892 ± 138.96477.861 ± 58.68581.301 ± 58.232142.691 ± 163.819
Week 52122.994 ± 108.549171.966 ± 166.209148.441 ± 140.495103.951 ± 63.290
SecondaryNumber of Participants With No Ovulation in 12 Months

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

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With No Ovulation in 12 Months
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Number of Participants With No Ovulation in 12 Months4783
SecondaryNumber of Participants With 1 or More Injection Site Reactions (ISRs)

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

Time frame:
Day 0 to Day 365
Reported as:
Count of participants · Participants
Number of Participants With 1 or More Injection Site Reactions (ISRs)
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Number of Participants With 1 or More Injection Site Reactions (ISRs)7664
SecondaryNumber of Participants With Responses to the Acceptability Question (What do You Like About the Method?)

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

Time frame:
Weeks 26 and 52
Reported as:
Count of participants · Participants
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Week 26: Easy to use7778
Week 26: Weight gain2141
Week 26: Weight loss1100
Week 26: Menstrual changes6535
Week 26: Discreet8845
Week 26: Provides longer-term protection than other method6443
Week 26: Few side effects5562
Week 26: Has to be administered by a healthcare provider2323
Week 26: Nothing1000
Week 26: Other1101
Week 52: Easy to use13111011
Week 52: Weight gain2431
Week 52: Weight loss2100
Week 52: Menstrual changes5434
Week 52: Discreet7669
Week 52: Provides longer-term protection than other method78310
Week 52: Few side effects10576
Week 52: Has to be administered by a healthcare provider2212
Week 52: Nothing0100
Week 52: Other0000
SecondaryNumber of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)

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

Time frame:
Weeks 26 and 52
Reported as:
Count of participants · Participants
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Week 26: Pain at injection2131
Week 26: Once injected, it cannot be reversed2100
Week 26: Weight gain1656
Week 26: Weight loss0000
Week 26: Nothing5225
Week 26: Menstrual changes7684
Week 26: Injection site reactions0000
Week 26: Other side effects3001
Week 26: Other0001
Week 52: Pain at injection2221
Week 52: Once injected, it cannot be reversed4300
Week 52: Weight gain1466
Week 52: Weight loss1000
Week 52: Nothing5135
Week 52: Menstrual changes8863
Week 52: Injection site reactions1210
Week 52: Other side effects1201
Week 52: Other0000
SecondaryNumber 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?)

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

Time frame:
Weeks 26 and 52
Reported as:
Count of participants · Participants
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?)
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Week 26 — Yes4223
Week 26 — No1110109
Week 52 — Yes2232
Week 52 — No14101112
SecondaryNumber of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)

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

Time frame:
Weeks 26 and 52
Reported as:
Count of participants · Participants
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
ParticipantsTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Week 26 — Injection every 1 month0100
Week 26 — Injection every 3 months3332
Week 26 — Injection every 6 months6554
Week 26 — Injection every 12 months5355
Week 26 — Frequency of reinjections is not important2002
Week 52 — Injection every 1 month0000
Week 52 — Injection every 3 months3221
Week 52 — Injection every 6 months2435
Week 52 — Injection every 12 months10676
Week 52 — Frequency of reinjections is not important1112
SecondaryProgesterone Concentration
Time frame:
Weeks 48, 49, 50, 51, and 52
Reported as:
Mean · ng/mL
Progesterone Concentration
ng/mLTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Week 482.103 ± 3.9930.945 ± 2.4222.255 ± 4.3952.682 ± 3.900
Week 491.803 ± 3.2682.448 ± 3.7841.593 ± 3.4714.323 ± 5.276
Week 504.793 ± 6.7915.224 ± 7.5541.649 ± 3.0853.086 ± 5.312
Week 514.280 ± 7.1330.795 ± 0.9281.214 ± 2.7371.669 ± 3.390
Week 522.096 ± 4.3192.264 ± 4.1672.561 ± 5.0692.529 ± 4.152

Adverse events

Collected over Day 0 up to Week 78. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TV46046 Dose A0/16 (0%)0/16 (0%)11/16 (68.8%)
TV46046 Dose B0/15 (0%)0/15 (0%)10/15 (66.7%)
TV46046 Dose C0/14 (0%)0/14 (0%)8/14 (57.1%)
Depo-subQ Provera0/15 (0%)1/15 (6.7%)12/15 (80%)
Most frequent serious events
Most frequent serious events
EventTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
Bile duct stoneHepatobiliary disorders0/160/150/141/15
Most frequent other events
Showing 10 of 54
Most frequent other events
EventTV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ Provera
HeadacheNervous system disorders6/162/151/144/15
FatigueGeneral disorders2/162/151/141/15
NasopharyngitisInfections and infestations0/160/150/142/15
Injection site painGeneral disorders2/161/151/141/15
Increased appetiteMetabolism and nutrition disorders2/160/150/140/15
Breast painReproductive system and breast disorders2/160/150/140/15
Injection site erythemaGeneral disorders1/160/151/140/15
Bronchitis viralInfections and infestations0/160/151/140/15
COVID-19Infections and infestations0/160/151/141/15
FuruncleInfections and infestations0/160/151/141/15

Baseline characteristics

Safety analysis set included all randomized participants who received an injection of study drug.

Age, Continuous
Age, Continuous(years)TV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ ProveraTotal
Mean35.3 ± 6.133.9 ± 7.231.2 ± 7.232.9 ± 6.333.4 ± 6.7
Sex: Female, Male
Sex: Female, Male(Participants)TV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ ProveraTotal
Female1615141560
Male00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TV46046 Dose ATV46046 Dose BTV46046 Dose CDepo-subQ ProveraTotal
American Indian or Alaska Native00000
Asian00101
Native Hawaiian or Other Pacific Islander00000
Black or African American141511
White845421
More than one race777627
Unknown or Not Reported00000
08

Study locations

3 sites
  • Teva Investigational Site 14002
    Cypress, California 90630, United States
  • Teva Investigational Site 14003
    San Antonio, Texas 78209, United States
  • Teva Investigational Site 18001
    Santo Domingo, 99999, Dominican Republic
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References and documents

Study documents

  • Study protocol · Mar 16, 2021
  • Statistical analysis plan · Feb 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04682353
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
FHI 360
Responsible party
Sponsor
First posted
Dec 23, 2020
Start date
Dec 14, 2020
Primary completion
Jul 11, 2022
Completion
Jan 12, 2023
Results posted
Feb 26, 2024
Last update
Feb 26, 2024

Study contacts

Teva Medical Expert, MD
study director · Teva Branded Pharmaceutical Products R&D, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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