Clinical trial NCT03700658: A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046
Official title: A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: FHI 360
First posted: 2018-10-09
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: Eligible participants will be enrolled and receive 1 of each of the 4 SC study injections in each abdominal quadrant approximately 1 hour apart: 120 milligrams (mg)/0.3 milliliter (mL) of TV-46046, 60 mg/0.3 mL of 1:1 saline diluted TV-46046, 0.3 mL of TV-46046 Placebo and 104 mg/0.65 mL Depo-subQ 104 per the assigned sequence.

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

Primary outcomes:
measure: Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain)
timeFrame: Day 0 (immediately after and 1 hour after the injection) up to Month 18
Secondary outcomes:
measure: Injection Site Pain Score, as Assessed by Numerical Rating Scale (NRS)
timeFrame: Day 0 (Immediately after and 1 hour after injection)
measure: Participant's Perception of Pain, as Assessed by an Overall Ranking of the 4 Study Injections From Least to Most Painful
timeFrame: Day 0 (1 hour after injection)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 0 up to Month 18
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Teva Investigational Site 1
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: