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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04682353

Enrollment

Registered

2020-12-23

Start date

2020-12-14

Completion date

2023-01-12

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Pharmacokinetics

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
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
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 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
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA	Day 0 to Day 365
Apparent Terminal Half-life (t½) of MPA	Day 0 to Day 365

Secondary

Measure	Time frame	Description
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 (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 Treatment-emergent Adverse Events (TEAEs)	Day 0 up to Week 78	—
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.
Progesterone Concentration	Weeks 48, 49, 50, 51, and 52	—
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.
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 Clinically Significant Changes in Vital Signs	Day 0 to Day 365	Vital signs examination included blood pressure, respiration rate, pulse, and body temperature.
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 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 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	—
Estradiol Concentrations	Baseline, Weeks 4, 13, 26, 30, and 52	—
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.

Countries

Dominican Republic, United States

Participant flow

Participants by arm

Arm	Count
TV46046 Dose A Participants received a single SC injection of TV-46046 Dose A.	16
TV46046 Dose B Participants received a single SC injection of TV-46046 Dose B.	15
TV46046 Dose C Participants received a single SC injection of TV-46046 Dose C.	14
Depo-subQ Provera Participants received a single SC injection of Depo-subQ Provera.	15
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	0	1	0	1
Overall Study	Personal reasons	0	1	0	0

Baseline characteristics

Characteristic	TV46046 Dose A	Total	Depo-subQ Provera	TV46046 Dose C	TV46046 Dose B
Age, Continuous	35.3 years STANDARD_DEVIATION 6.1	33.4 years STANDARD_DEVIATION 6.7	32.9 years STANDARD_DEVIATION 6.3	31.2 years STANDARD_DEVIATION 7.2	33.9 years STANDARD_DEVIATION 7.2
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	11 Participants	5 Participants	1 Participants	4 Participants
Race (NIH/OMB) More than one race	7 Participants	27 Participants	6 Participants	7 Participants	7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	8 Participants	21 Participants	4 Participants	5 Participants	4 Participants
Sex: Female, Male Female	16 Participants	60 Participants	15 Participants	14 Participants	15 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 15	0 / 14	0 / 15
other Total, other adverse events	11 / 16	10 / 15	8 / 14	12 / 15
serious Total, serious adverse events	0 / 16	0 / 15	0 / 14	1 / 15

Outcome results

Primary

Apparent Terminal Half-life (t½) of MPA

Time frame: Day 0 to Day 365

Population: 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.

Arm	Measure	Value (MEDIAN)
TV46046 Dose A	Apparent Terminal Half-life (t½) of MPA	47.4 days
TV46046 Dose B	Apparent Terminal Half-life (t½) of MPA	85.3 days
TV46046 Dose C	Apparent Terminal Half-life (t½) of MPA	79.8 days
Depo-subQ Provera	Apparent Terminal Half-life (t½) of MPA	37.4 days

Primary

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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TV46046 Dose A	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA	94.2 days*ng/mL	Geometric Coefficient of Variation 27
TV46046 Dose B	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA	121.8 days*ng/mL	Geometric Coefficient of Variation 38.1
TV46046 Dose C	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA	173.6 days*ng/mL	Geometric Coefficient of Variation 25.8
Depo-subQ Provera	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA	86.1 days*ng/mL	Geometric Coefficient of Variation 29.6

90% CI: [0.92, 1.302]

90% CI: [1.148, 1.744]

90% CI: [1.692, 2.405]

Primary

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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TV46046 Dose A	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA	100.2 days*ng/mL	Geometric Coefficient of Variation 23.9
TV46046 Dose B	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA	129.6 days*ng/mL	Geometric Coefficient of Variation 37.8
TV46046 Dose C	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA	187.0 days*ng/mL	Geometric Coefficient of Variation 26
Depo-subQ Provera	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA	90.1 days*ng/mL	Geometric Coefficient of Variation 27.6

90% CI: [0.948, 1.303]

90% CI: [1.174, 1.762]

90% CI: [1.751, 2.459]

Primary

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

Time frame: Day 0 to Day 365

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TV46046 Dose A	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA	117.2 days*ng/mL	Geometric Coefficient of Variation 17.9
TV46046 Dose B	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA	160.8 days*ng/mL	Geometric Coefficient of Variation 36.6
TV46046 Dose C	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA	224.9 days*ng/mL	Geometric Coefficient of Variation 18.9
Depo-subQ Provera	Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA	105.1 days*ng/mL	Geometric Coefficient of Variation 19.5

90% CI: [0.993, 1.252]

90% CI: [1.277, 1.833]

90% CI: [1.888, 2.425]

Primary

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

Time frame: Day 0 to Day 365

Population: 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.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TV46046 Dose A	Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)	0.940 nanograms (ng)/ milliliter (mL)	Geometric Coefficient of Variation 41.187
TV46046 Dose B	Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)	1.180 nanograms (ng)/ milliliter (mL)	Geometric Coefficient of Variation 39.076
TV46046 Dose C	Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)	1.750 nanograms (ng)/ milliliter (mL)	Geometric Coefficient of Variation 41.407
Depo-subQ Provera	Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)	0.963 nanograms (ng)/ milliliter (mL)	Geometric Coefficient of Variation 47.672

90% CI: [0.748, 1.274]

90% CI: [0.94, 1.598]

90% CI: [1.38, 2.392]

Primary

Serum MPA Concentration at Day 182 (C182)

Time frame: Day 182

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TV46046 Dose A	Serum MPA Concentration at Day 182 (C182)	0.201 ng/mL	Geometric Coefficient of Variation 69.429
TV46046 Dose B	Serum MPA Concentration at Day 182 (C182)	0.279 ng/mL	Geometric Coefficient of Variation 65.793
TV46046 Dose C	Serum MPA Concentration at Day 182 (C182)	0.443 ng/mL	Geometric Coefficient of Variation 60.531
Depo-subQ Provera	Serum MPA Concentration at Day 182 (C182)	0.118 ng/mL	Geometric Coefficient of Variation 150.789

90% CI: [0.921, 3.135]

90% CI: [1.273, 4.39]

90% CI: [2.033, 6.908]

Primary

Serum MPA Concentration at Day 210 (C210)

Time frame: Day 210

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TV46046 Dose A	Serum MPA Concentration at Day 210 (C210)	0.119 ng/mL	Geometric Coefficient of Variation 105.727
TV46046 Dose B	Serum MPA Concentration at Day 210 (C210)	0.208 ng/mL	Geometric Coefficient of Variation 76.683
TV46046 Dose C	Serum MPA Concentration at Day 210 (C210)	0.365 ng/mL	Geometric Coefficient of Variation 69.357
Depo-subQ Provera	Serum MPA Concentration at Day 210 (C210)	0.063 ng/mL	Geometric Coefficient of Variation 244.107

90% CI: [0.886, 4.093]

90% CI: [1.585, 6.942]

90% CI: [2.796, 12.135]

Primary

Serum MPA Concentration at Day 91 (C91)

Time frame: Day 91

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TV46046 Dose A	Serum MPA Concentration at Day 91 (C91)	0.570 ng/mL	Geometric Coefficient of Variation 36.802
TV46046 Dose B	Serum MPA Concentration at Day 91 (C91)	0.660 ng/mL	Geometric Coefficient of Variation 49.36
TV46046 Dose C	Serum MPA Concentration at Day 91 (C91)	1.090 ng/mL	Geometric Coefficient of Variation 40.151
Depo-subQ Provera	Serum MPA Concentration at Day 91 (C91)	0.474 ng/mL	Geometric Coefficient of Variation 37.765

90% CI: [0.96, 1.506]

90% CI: [1.07, 1.815]

90% CI: [1.806, 2.933]

Primary

Time to Reach Cmax (Tmax) of MPA

Time frame: Day 0 to Day 365

Arm	Measure	Value (MEDIAN)
TV46046 Dose A	Time to Reach Cmax (Tmax) of MPA	17.0 days
TV46046 Dose B	Time to Reach Cmax (Tmax) of MPA	28.0 days
TV46046 Dose C	Time to Reach Cmax (Tmax) of MPA	6.0 days
Depo-subQ Provera	Time to Reach Cmax (Tmax) of MPA	31.5 days

Secondary

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

Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint.

Arm	Measure	Group	Value (MEAN)	Dispersion
TV46046 Dose A	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Day 7	-0.21 kilograms (kg)	Standard Error 0.19
TV46046 Dose A	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 13	-1.10 kilograms (kg)	Standard Error 1.42
TV46046 Dose A	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 26	1.14 kilograms (kg)	Standard Error 0.58
TV46046 Dose A	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 52	0.60 kilograms (kg)	Standard Error 0.56
TV46046 Dose B	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 52	1.38 kilograms (kg)	Standard Error 1
TV46046 Dose B	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 26	2.91 kilograms (kg)	Standard Error 1.11
TV46046 Dose B	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 13	0.92 kilograms (kg)	Standard Error 0.65
TV46046 Dose B	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Day 7	-0.27 kilograms (kg)	Standard Error 0.2
TV46046 Dose C	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 26	1.38 kilograms (kg)	Standard Error 0.74
TV46046 Dose C	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 52	0.79 kilograms (kg)	Standard Error 1.06
TV46046 Dose C	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 13	0.84 kilograms (kg)	Standard Error 0.35
TV46046 Dose C	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Day 7	-0.33 kilograms (kg)	Standard Error 0.17
Depo-subQ Provera	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 52	1.99 kilograms (kg)	Standard Error 0.91
Depo-subQ Provera	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Day 7	0.05 kilograms (kg)	Standard Error 0.28
Depo-subQ Provera	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 13	1.40 kilograms (kg)	Standard Error 0.87
Depo-subQ Provera	Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52	Change at Week 26	2.68 kilograms (kg)	Standard Error 0.89

Secondary

Estradiol Concentrations

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

Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint.

Arm	Measure	Group	Value (MEAN)	Dispersion
TV46046 Dose A	Estradiol Concentrations	Baseline	64.988 picograms (pg)/mL	Standard Deviation 57.169
TV46046 Dose A	Estradiol Concentrations	Week 4	72.357 picograms (pg)/mL	Standard Deviation 38.855
TV46046 Dose A	Estradiol Concentrations	Week 13	62.389 picograms (pg)/mL	Standard Deviation 56.316
TV46046 Dose A	Estradiol Concentrations	Week 26	114.347 picograms (pg)/mL	Standard Deviation 67.997
TV46046 Dose A	Estradiol Concentrations	Week 30	133.892 picograms (pg)/mL	Standard Deviation 138.964
TV46046 Dose A	Estradiol Concentrations	Week 52	122.994 picograms (pg)/mL	Standard Deviation 108.549
TV46046 Dose B	Estradiol Concentrations	Week 52	171.966 picograms (pg)/mL	Standard Deviation 166.209
TV46046 Dose B	Estradiol Concentrations	Week 26	177.369 picograms (pg)/mL	Standard Deviation 197.661
TV46046 Dose B	Estradiol Concentrations	Baseline	52.825 picograms (pg)/mL	Standard Deviation 22.857
TV46046 Dose B	Estradiol Concentrations	Week 13	45.890 picograms (pg)/mL	Standard Deviation 30.475
TV46046 Dose B	Estradiol Concentrations	Week 4	49.027 picograms (pg)/mL	Standard Deviation 48.373
TV46046 Dose B	Estradiol Concentrations	Week 30	77.861 picograms (pg)/mL	Standard Deviation 58.685
TV46046 Dose C	Estradiol Concentrations	Week 4	31.149 picograms (pg)/mL	Standard Deviation 13.394
TV46046 Dose C	Estradiol Concentrations	Week 13	36.337 picograms (pg)/mL	Standard Deviation 25.065
TV46046 Dose C	Estradiol Concentrations	Week 26	52.132 picograms (pg)/mL	Standard Deviation 38.971
TV46046 Dose C	Estradiol Concentrations	Week 52	148.441 picograms (pg)/mL	Standard Deviation 140.495
TV46046 Dose C	Estradiol Concentrations	Week 30	81.301 picograms (pg)/mL	Standard Deviation 58.232
TV46046 Dose C	Estradiol Concentrations	Baseline	63.962 picograms (pg)/mL	Standard Deviation 74.815
Depo-subQ Provera	Estradiol Concentrations	Week 30	142.691 picograms (pg)/mL	Standard Deviation 163.819
Depo-subQ Provera	Estradiol Concentrations	Week 52	103.951 picograms (pg)/mL	Standard Deviation 63.29
Depo-subQ Provera	Estradiol Concentrations	Week 4	55.699 picograms (pg)/mL	Standard Deviation 28.077
Depo-subQ Provera	Estradiol Concentrations	Week 26	105.234 picograms (pg)/mL	Standard Deviation 67.421
Depo-subQ Provera	Estradiol Concentrations	Baseline	66.181 picograms (pg)/mL	Standard Deviation 64.843
Depo-subQ Provera	Estradiol Concentrations	Week 13	42.071 picograms (pg)/mL	Standard Deviation 30.137

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.

Time frame: Day 0 to Day 365

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With 1 or More Injection Site Reactions (ISRs)	7 Participants
TV46046 Dose B	Number of Participants With 1 or More Injection Site Reactions (ISRs)	6 Participants
TV46046 Dose C	Number of Participants With 1 or More Injection Site Reactions (ISRs)	6 Participants
Depo-subQ Provera	Number of Participants With 1 or More Injection Site Reactions (ISRs)	4 Participants

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.

Time frame: Day 0 up to Week 78

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With at Least 1 Concomitant Medication Use During Treatment	11 Participants
TV46046 Dose B	Number of Participants With at Least 1 Concomitant Medication Use During Treatment	8 Participants
TV46046 Dose C	Number of Participants With at Least 1 Concomitant Medication Use During Treatment	6 Participants
Depo-subQ Provera	Number of Participants With at Least 1 Concomitant Medication Use During Treatment	10 Participants

Secondary

Number of Participants With Clinically Significant Changes in Liver Function Tests

Time frame: Day 0 to Day 365

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With Clinically Significant Changes in Liver Function Tests	0 Participants
TV46046 Dose B	Number of Participants With Clinically Significant Changes in Liver Function Tests	0 Participants
TV46046 Dose C	Number of Participants With Clinically Significant Changes in Liver Function Tests	0 Participants
Depo-subQ Provera	Number of Participants With Clinically Significant Changes in Liver Function Tests	0 Participants

Secondary

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

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants
TV46046 Dose B	Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants
TV46046 Dose C	Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants
Depo-subQ Provera	Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants

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.

Time frame: 12 months

Population: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With No Ovulation in 12 Months	4 Participants
TV46046 Dose B	Number of Participants With No Ovulation in 12 Months	7 Participants
TV46046 Dose C	Number of Participants With No Ovulation in 12 Months	8 Participants
Depo-subQ Provera	Number of Participants With No Ovulation in 12 Months	3 Participants

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.

Time frame: Weeks 13, 26, and 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 52	Acceptable	14 Participants
TV46046 Dose A	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 13	Not Acceptable	6 Participants
TV46046 Dose A	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 52	Not Acceptable	2 Participants
TV46046 Dose A	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 26	Acceptable	12 Participants
TV46046 Dose A	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 26	Not Acceptable	4 Participants
TV46046 Dose A	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 13	Acceptable	10 Participants
TV46046 Dose B	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 13	Not Acceptable	5 Participants
TV46046 Dose B	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 13	Acceptable	9 Participants
TV46046 Dose B	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 26	Acceptable	13 Participants
TV46046 Dose B	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 52	Acceptable	12 Participants
TV46046 Dose B	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 26	Not Acceptable	1 Participants
TV46046 Dose B	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 52	Not Acceptable	1 Participants
TV46046 Dose C	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 13	Acceptable	11 Participants
TV46046 Dose C	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 13	Not Acceptable	3 Participants
TV46046 Dose C	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 52	Acceptable	13 Participants
TV46046 Dose C	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 26	Not Acceptable	4 Participants
TV46046 Dose C	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 52	Not Acceptable	1 Participants
TV46046 Dose C	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 26	Acceptable	9 Participants
Depo-subQ Provera	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 52	Not Acceptable	1 Participants
Depo-subQ Provera	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 13	Acceptable	11 Participants
Depo-subQ Provera	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 13	Not Acceptable	4 Participants
Depo-subQ Provera	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 26	Acceptable	12 Participants
Depo-subQ Provera	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 26	Not Acceptable	1 Participants
Depo-subQ Provera	Number of Participants With Overall Opinion of Vaginal Bleeding Pattern	Week 52	Acceptable	13 Participants

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.

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

Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Moderate Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Mild Depression	2 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Minimal Depression	6 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Mild Depression	1 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Mild Depression	1 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	No Depression	8 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Moderate Depression	1 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Mild Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Moderately Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Minimal Depression	4 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	No Depression	11 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Moderate Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Moderately Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Moderately Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Moderately Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Minimal Depression	4 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Moderate Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Mild Depression	2 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	No Depression	12 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Minimal Depression	4 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	No Depression	10 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	No Depression	9 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Moderate Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Moderately Severe Depression	0 Participants
TV46046 Dose A	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Minimal Depression	5 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Minimal Depression	4 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	No Depression	9 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Minimal Depression	4 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Mild Depression	2 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Moderate Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Moderately Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	No Depression	10 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Mild Depression	1 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Moderate Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Moderately Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	No Depression	6 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Minimal Depression	7 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Mild Depression	2 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Moderate Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Moderately Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	No Depression	7 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Minimal Depression	5 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Mild Depression	2 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Moderate Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Moderately Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	No Depression	6 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Minimal Depression	5 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Mild Depression	1 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Moderate Depression	1 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Moderately Severe Depression	0 Participants
TV46046 Dose B	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Minimal Depression	3 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	No Depression	10 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	No Depression	10 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Moderate Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Mild Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Moderately Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	No Depression	9 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	No Depression	10 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Minimal Depression	2 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Moderate Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Mild Depression	1 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Moderately Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Moderate Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Moderate Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Moderately Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Mild Depression	1 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Moderately Severe Depression	1 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Moderate Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Moderately Severe Depression	1 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Severe Depression	0 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Mild Depression	1 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Minimal Depression	3 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	No Depression	9 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Minimal Depression	5 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Minimal Depression	3 Participants
TV46046 Dose C	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Mild Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	No Depression	9 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Moderately Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Moderately Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Mild Depression	1 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Moderate Depression	1 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	No Depression	6 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Minimal Depression	7 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Moderately Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Mild Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Minimal Depression	2 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Mild Depression	1 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Minimal Depression	5 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	No Depression	10 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	No Depression	12 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Moderate Depression	1 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Minimal Depression	2 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Moderately Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	Minimal Depression	4 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Baseline	Moderate Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Mild Depression	1 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 13	No Depression	9 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 52	Moderate Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Moderately Severe Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 26	Moderate Depression	0 Participants
Depo-subQ Provera	Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores	Week 4	Mild Depression	1 Participants

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.

Time frame: Weeks 26 and 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 1 month	0 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 6 months	6 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 12 months	10 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Frequency of reinjections is not important	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 12 months	5 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 6 months	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 3 months	3 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 3 months	3 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Frequency of reinjections is not important	1 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 1 month	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Frequency of reinjections is not important	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 1 month	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 12 months	6 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 3 months	3 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 6 months	5 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 12 months	3 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 1 month	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 3 months	2 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 6 months	4 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Frequency of reinjections is not important	1 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 1 month	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Frequency of reinjections is not important	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Frequency of reinjections is not important	1 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 6 months	3 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 3 months	3 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 1 month	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 12 months	7 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 12 months	5 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 3 months	2 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 6 months	5 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 3 months	1 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Frequency of reinjections is not important	2 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 1 month	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 1 month	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Frequency of reinjections is not important	2 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 3 months	2 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 12 months	6 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 52	Injection every 6 months	5 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 6 months	4 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)	Week 26	Injection every 12 months	5 Participants

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.

Time frame: Weeks 26 and 52

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	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?)	Week 52	No	14 Participants
TV46046 Dose A	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?)	Week 52	Yes	2 Participants
TV46046 Dose A	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?)	Week 26	Yes	4 Participants
TV46046 Dose A	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?)	Week 26	No	11 Participants
TV46046 Dose B	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?)	Week 26	Yes	2 Participants
TV46046 Dose B	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?)	Week 26	No	10 Participants
TV46046 Dose B	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?)	Week 52	No	10 Participants
TV46046 Dose B	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?)	Week 52	Yes	2 Participants
TV46046 Dose C	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?)	Week 52	Yes	3 Participants
TV46046 Dose C	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?)	Week 26	Yes	2 Participants
TV46046 Dose C	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?)	Week 26	No	10 Participants
TV46046 Dose C	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?)	Week 52	No	11 Participants
Depo-subQ Provera	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?)	Week 26	Yes	3 Participants
Depo-subQ Provera	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?)	Week 52	Yes	2 Participants
Depo-subQ Provera	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?)	Week 52	No	12 Participants
Depo-subQ Provera	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?)	Week 26	No	9 Participants

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.

Time frame: Weeks 26 and 52

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Provides longer-term protection than other method	7 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Easy to use	13 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Weight loss	1 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Menstrual changes	5 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Weight gain	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Easy to use	7 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Weight loss	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Nothing	0 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Menstrual changes	6 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Discreet	8 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Has to be administered by a healthcare provider	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Provides longer-term protection than other method	6 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Other	0 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Few side effects	5 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Weight gain	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Few side effects	10 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Has to be administered by a healthcare provider	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Nothing	1 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Discreet	7 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Other	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Few side effects	5 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Other	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Nothing	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Menstrual changes	4 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Discreet	8 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Easy to use	11 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Other	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Weight gain	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Provides longer-term protection than other method	8 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Weight gain	4 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Provides longer-term protection than other method	4 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Weight loss	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Nothing	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Weight loss	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Discreet	6 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Few side effects	5 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Has to be administered by a healthcare provider	3 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Menstrual changes	5 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Easy to use	7 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Has to be administered by a healthcare provider	2 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Weight gain	3 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Easy to use	7 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Discreet	6 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Weight gain	4 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Weight loss	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Menstrual changes	3 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Discreet	4 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Provides longer-term protection than other method	4 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Few side effects	6 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Has to be administered by a healthcare provider	2 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Nothing	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Other	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Easy to use	10 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Weight loss	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Menstrual changes	3 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Provides longer-term protection than other method	3 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Few side effects	7 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Has to be administered by a healthcare provider	1 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Nothing	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Other	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Nothing	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Has to be administered by a healthcare provider	3 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Nothing	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Provides longer-term protection than other method	10 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Few side effects	2 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Provides longer-term protection than other method	3 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Easy to use	8 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Few side effects	6 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Discreet	5 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Menstrual changes	5 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Discreet	9 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Has to be administered by a healthcare provider	2 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Weight loss	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Weight gain	1 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Weight gain	1 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Weight loss	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Easy to use	11 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 26: Other	1 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Other	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)	Week 52: Menstrual changes	4 Participants

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.

Time frame: Weeks 26 and 52

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Pain at injection	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Other	0 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Menstrual changes	7 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Other	0 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Other side effects	3 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Injection site reactions	0 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Injection site reactions	1 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Menstrual changes	8 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Weight gain	1 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Pain at injection	2 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Nothing	5 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Weight loss	1 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Weight loss	0 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Other side effects	1 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Weight gain	1 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Once injected, it cannot be reversed	4 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Nothing	5 Participants
TV46046 Dose A	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Once injected, it cannot be reversed	2 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Weight gain	6 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Pain at injection	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Once injected, it cannot be reversed	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Weight loss	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Nothing	2 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Menstrual changes	6 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Injection site reactions	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Other side effects	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Other	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Pain at injection	2 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Once injected, it cannot be reversed	3 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Weight gain	4 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Weight loss	0 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Nothing	1 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Menstrual changes	8 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Injection site reactions	2 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Other side effects	2 Participants
TV46046 Dose B	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Other	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Nothing	2 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Pain at injection	2 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Once injected, it cannot be reversed	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Weight loss	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Other	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Weight gain	6 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Other side effects	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Weight loss	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Weight gain	5 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Nothing	3 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Pain at injection	3 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Menstrual changes	6 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Once injected, it cannot be reversed	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Injection site reactions	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Menstrual changes	8 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Other side effects	0 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Injection site reactions	1 Participants
TV46046 Dose C	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Other	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Injection site reactions	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Injection site reactions	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Nothing	5 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Pain at injection	1 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Weight loss	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Pain at injection	1 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Once injected, it cannot be reversed	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Once injected, it cannot be reversed	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Nothing	5 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Other	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Menstrual changes	3 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Weight gain	6 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Weight gain	6 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Menstrual changes	4 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Other	1 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Weight loss	0 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 26: Other side effects	1 Participants
Depo-subQ Provera	Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)	Week 52: Other side effects	1 Participants

Secondary

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

Time frame: Day 0 up to Week 78

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TV46046 Dose A	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	11 Participants
TV46046 Dose B	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	10 Participants
TV46046 Dose C	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	8 Participants
Depo-subQ Provera	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	12 Participants

Secondary

Progesterone Concentration

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

Arm	Measure	Group	Value (MEAN)	Dispersion
TV46046 Dose A	Progesterone Concentration	Week 49	1.803 ng/mL	Standard Deviation 3.268
TV46046 Dose A	Progesterone Concentration	Week 48	2.103 ng/mL	Standard Deviation 3.993
TV46046 Dose A	Progesterone Concentration	Week 50	4.793 ng/mL	Standard Deviation 6.791
TV46046 Dose A	Progesterone Concentration	Week 51	4.280 ng/mL	Standard Deviation 7.133
TV46046 Dose A	Progesterone Concentration	Week 52	2.096 ng/mL	Standard Deviation 4.319
TV46046 Dose B	Progesterone Concentration	Week 50	5.224 ng/mL	Standard Deviation 7.554
TV46046 Dose B	Progesterone Concentration	Week 48	0.945 ng/mL	Standard Deviation 2.422
TV46046 Dose B	Progesterone Concentration	Week 49	2.448 ng/mL	Standard Deviation 3.784
TV46046 Dose B	Progesterone Concentration	Week 51	0.795 ng/mL	Standard Deviation 0.928
TV46046 Dose B	Progesterone Concentration	Week 52	2.264 ng/mL	Standard Deviation 4.167
TV46046 Dose C	Progesterone Concentration	Week 49	1.593 ng/mL	Standard Deviation 3.471
TV46046 Dose C	Progesterone Concentration	Week 50	1.649 ng/mL	Standard Deviation 3.085
TV46046 Dose C	Progesterone Concentration	Week 48	2.255 ng/mL	Standard Deviation 4.395
TV46046 Dose C	Progesterone Concentration	Week 52	2.561 ng/mL	Standard Deviation 5.069
TV46046 Dose C	Progesterone Concentration	Week 51	1.214 ng/mL	Standard Deviation 2.737
Depo-subQ Provera	Progesterone Concentration	Week 48	2.682 ng/mL	Standard Deviation 3.9
Depo-subQ Provera	Progesterone Concentration	Week 51	1.669 ng/mL	Standard Deviation 3.39
Depo-subQ Provera	Progesterone Concentration	Week 50	3.086 ng/mL	Standard Deviation 5.312
Depo-subQ Provera	Progesterone Concentration	Week 52	2.529 ng/mL	Standard Deviation 4.152
Depo-subQ Provera	Progesterone Concentration	Week 49	4.323 ng/mL	Standard Deviation 5.276

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Apparent Terminal Half-life (t½) of MPA

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

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

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

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

Serum MPA Concentration at Day 182 (C182)

Serum MPA Concentration at Day 210 (C210)

Serum MPA Concentration at Day 91 (C91)

Time to Reach Cmax (Tmax) of MPA

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

Estradiol Concentrations

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

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

Number of Participants With Clinically Significant Changes in Liver Function Tests

Number of Participants With Clinically Significant Changes in Vital Signs

Number of Participants With No Ovulation in 12 Months

Number of Participants With Overall Opinion of Vaginal Bleeding Pattern

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

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

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?)

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

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

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

Progesterone Concentration