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Completed

NCT Number: NCT03700658

A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046

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.

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Key information

Conditions

Contraception

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 1

Santo Domingo, Dominican Republic

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TV-46046

Drug

TV-46046 will be administered per dose and schedule specified in the arm.

Depo-subQ 104

Drug

Depo-subQ 104 will be administered per dose and schedule specified in the arm.

Other names: Medroxyprogesterone acetate injectable suspension, Depo-subQ Provera 104®

TV-46046 Placebo

Drug

TV-46046 Placebo will be administered per schedule specified in the arm.

Primary outcomes

  1. Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain)

    Time frame: Day 0 (immediately after and 1 hour after the injection) up to Month 18

    ISRs were assessed by self-reports and direct observation for each injection at least twice on the day of injection. ISRs included erythema (redness), swelling, pruritus (itching), bleeding, bruising, injection site discoloration (for example, hypopigmentation), or atrophy (that is, dimple).

Secondary outcomes

  1. Injection Site Pain Score, as Assessed by Numerical Rating Scale (NRS)

    Time frame: Day 0 (Immediately after and 1 hour after injection)

    Participants assessed their injection site pain using an 11-point NRS (0 = no pain at all; 10 = worst pain). Higher scores denote worse outcome.

  2. Participant's Perception of Pain, as Assessed by an Overall Ranking of the 4 Study Injections From Least to Most Painful

    Time frame: Day 0 (1 hour after injection)

    Each participant was asked to rank the injections according to overall pain from least (score = 1) to most (score = 4) painful. If a participant could not rank all of her injections from least to most painful or could not uniquely identify which injection was the most painful, then her responses were appropriately weighted across groups (for example, if a participant ranked all 4 treatments as equally most painful, then that participant contributed a score of 0.25 to each group when assessing the distribution of the most painful injection and in the event of a tie between 2 rankings, 0.5 was assigned to each tied ranking).

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Day 0 up to Month 18

    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were considered treatment emergent if (a) the onset occurred on or after the time of first injection or (b) an event had an onset prior to the first injection but increased in severity after administration of the injection. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Collaborators

  • FHI 360

Registry information

Official study title

A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2018
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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