Phase 1
Completed N=27
A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046
Source: ClinicalTrials.gov NCT03700658 ↗Enrolled (actual)
27
Serious AEs
0.7%
Results posted
Jan 2022
Primary outcomePrimary: Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain) — 12; 6; 0; 8 Participants
Summary
The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain) |
12; 6; 0; 8 | — |
| SECONDARY Injection Site Pain Score, as Assessed by Numerical Rating Scale (NRS) |
2.1; 1.9; 3.3; 1.2; 0.2; 0.2 | — |
| SECONDARY Participant's Perception of Pain, as Assessed by an Overall Ranking of the 4 Study Injections From Least to Most Painful |
4; 5; 4; 9; 8.5; 8.5 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
23 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device [IUD], or consistent use of condoms)
- Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
- Participant had a normal mammogram within the last year, if 40 years or older
- Participant has no skin disorders or skin allergies
- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria
- Participant has hypertension
- Participant has ischemic heart disease or a history of ischemic heart disease
- Participant has a history of stroke
- Participant has a history of thromboembolic event(s)
- Participant has systemic lupus erythematosus
- Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
- Participant has migraine with aura
- Participant has unexplained vaginal bleeding
- Participant has diabetes
- Participant has a strong family history of breast cancer
- Participant has cervical cancer or a history of cervical cancer
- Participant has severe cirrhosis (decompensated) or liver tumors
- Participant has known significant renal disease
- Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
- Participant is currently using hormonal contraception
- Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
- Participant is chronically using pain medication
- Participant has a plan to move to another location in the next 18 months
- Additional criteria apply, please contact the investigator for more information
Data sourced from ClinicalTrials.gov (NCT03700658). 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.