| Primary | Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA) | | Pharmacokinetic (PK) analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanograms (ng)/ milliliter (mL) | | Day 0 to Day 365 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| | Units | Counts |
|---|
| Participants | - OG00016
- OG00115
- OG00214
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.940± 41.187
- OG0011.180± 39.076
- OG0021.750± 41.407
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Geometric Mean Ratio | 0.976 | | | 2-Sided | 90 | 0.748 | 1.274 | | | | | Other | | | | | | | | |
|
| Primary | Time to Reach Cmax (Tmax) of MPA | | PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. | Posted | | Median | Full Range | days | | Day 0 to Day 365 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Primary | Serum MPA Concentration at Day 91 (C91) | | PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 91 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Primary | Serum MPA Concentration at Day 182 (C182) | | PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 182 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
|
| Primary | Serum MPA Concentration at Day 210 (C210) | | PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 210 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
|
| Primary | Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA | | PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days*ng/mL | | Day 0 to Day 182 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Primary | Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA | | PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days*ng/mL | | Day 0 to Day 210 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Primary | Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA | | PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days*ng/mL | | Day 0 to Day 365 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
|
| Primary | Apparent Terminal Half-life (t½) of MPA | | PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Median | Full Range | days | | Day 0 to Day 365 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | | Safety analysis set included all randomized participants who received an injection of study drug. | Posted | | Count of Participants | | Participants | | Day 0 up to Week 78 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. | Posted | | Count of Participants | | Participants | | Day 0 up to Week 78 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs | Vital signs examination included blood pressure, respiration rate, pulse, and body temperature. | Safety analysis set included all randomized participants who received an injection of study drug. | Posted | | Count of Participants | | Participants | | Day 0 to Day 365 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52 | | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint. | Posted | | Mean | Standard Error | kilograms (kg) | | Day 7 and Weeks 13, 26, and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | | Count of Participants | | Participants | | Weeks 13, 26, and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
|
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint. | Posted | | Count of Participants | | Participants | | Baseline, Weeks 4, 13, 26, and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | |
|
| Secondary | Number of Participants With Clinically Significant Changes in Liver Function Tests | | Safety analysis set included all randomized participants who received an injection of study drug. | Posted | | Count of Participants | | Participants | | Day 0 to Day 365 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | Estradiol Concentrations | | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint. | Posted | | Mean | Standard Deviation | picograms (pg)/mL | | Baseline, Weeks 4, 13, 26, 30, and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. | Posted | | Count of Participants | | Participants | | Day 0 to Day 365 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. | Posted | | Count of Participants | | Participants | | Weeks 26 and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
|
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. | Posted | | Count of Participants | | Participants | | Weeks 26 and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
|
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | | Count of Participants | | Participants | | Weeks 26 and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
|
| Secondary | 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. | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | | Count of Participants | | Participants | | Weeks 26 and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
|
| Secondary | Progesterone Concentration | | Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | | Mean | Standard Deviation | ng/mL | | Weeks 48, 49, 50, 51, and 52 | | | | ID | Title | Description |
|---|
| OG000 | TV46046 Dose A | Participants received a single SC injection of TV-46046 Dose A. | | OG001 | TV46046 Dose B | Participants received a single SC injection of TV-46046 Dose B. | | OG002 | TV46046 Dose C | Participants received a single SC injection of TV-46046 Dose C. | | OG003 | Depo-subQ Provera | Participants received a single SC injection of Depo-subQ Provera. |
| |