Phase 1
Completed N=60
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
Source: ClinicalTrials.gov NCT04682353 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Feb 2024
Primary outcomePrimary: Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA) — 0.940; 1.180; 1.750; 0.963 nanograms (ng)/ milliliter (mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA) |
0.940; 1.180; 1.750; 0.963 | — |
| PRIMARY Time to Reach Cmax (Tmax) of MPA |
17.0; 28.0; 6.0; 31.5 | — |
| PRIMARY Serum MPA Concentration at Day 91 (C91) |
0.570; 0.660; 1.090; 0.474 | — |
| PRIMARY Serum MPA Concentration at Day 182 (C182) |
0.201; 0.279; 0.443; 0.118 | — |
| PRIMARY Serum MPA Concentration at Day 210 (C210) |
0.119; 0.208; 0.365; 0.063 | — |
| PRIMARY Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA |
94.2; 121.8; 173.6; 86.1 | — |
| PRIMARY Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA |
100.2; 129.6; 187.0; 90.1 | — |
| PRIMARY Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA |
117.2; 160.8; 224.9; 105.1 | — |
| PRIMARY Apparent Terminal Half-life (t½) of MPA |
47.4; 85.3; 79.8; 37.4 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
11; 10; 8; 12 | — |
| SECONDARY Number of Participants With at Least 1 Concomitant Medication Use During Treatment |
11; 8; 6; 10 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52 |
-0.21; -0.27; -0.33; 0.05; -1.10; 0.92 | — |
| SECONDARY Number of Participants With Overall Opinion of Vaginal Bleeding Pattern |
10; 9; 11; 11; 6; 5 | — |
| SECONDARY Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores |
12; 9; 10; 9; 4; 4 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Liver Function Tests |
0; 0; 0; 0 | — |
| SECONDARY Estradiol Concentrations |
64.988; 52.825; 63.962; 66.181; 72.357; 49.027 | — |
| SECONDARY Number of Participants With No Ovulation in 12 Months |
4; 7; 8; 3 | — |
| SECONDARY Number of Participants With 1 or More Injection Site Reactions (ISRs) |
7; 6; 6; 4 | — |
| SECONDARY Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?) |
7; 7; 7; 8; 2; 1 | — |
| SECONDARY Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?) |
2; 1; 3; 1; 2; 1 | — |
| 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?) |
4; 2; 2; 3; 11; 10 | — |
| SECONDARY Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?) |
0; 1; 0; 0; 3; 3 | — |
| SECONDARY Progesterone Concentration |
2.103; 0.945; 2.255; 2.682; 1.803; 2.448 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04682353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.