A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046
Condition: Contraception
Intervention: TV-46046; Depo-subQ 104; TV-46046 Placebo
Intervention description: TV-46046 will be administered per dose and schedule specified in the arm.; Depo-subQ 104 will be administered per dose and schedule specified in the arm.; TV-46046 Placebo will be administered per schedule specified in the arm.
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Masking description: The study will be partially blinded due to differences in appearance and volume of the treatments. Designated unblinded study staff will conduct randomization procedures. The staff preparing and administering injections will also be unblinded to treatment sequence but will be trained to shield the syringe prior to and at the time of injection from view of the participant and study staff assessing injection site reactions (ISRs).
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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