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COL-1077 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| COL-1077 | ACTIVE_COMPARATOR | lidocaine bioadhesive gel, 10% |
| Placebo | PLACEBO_COMPARATOR | placebo bioadhesive gel |
| Name | Type | Description |
|---|---|---|
| COL-1077 | DRUG | single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion |
| Placebo | DRUG | single dose of bioadhesive gel administered by intravaginal insertion |
Inclusion Criteria: 1. Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age 2. For those women who are thought to be postmenopausal, postmenopausal will be defined as at least 6 months of confirmed amenorrhea with follicle stimulating hormone (FSH) levels of ≥ 40.0 mIU/mL 3. Scheduled to...
COL-1077 is an investigational small molecule being studied for use in endometrial biopsy. It is formulated as a lidocaine bioadhesive gel at 10% concentration and is intended to provide local anesthesia for women undergoing transvaginal pipelle-directed endometrial biopsy. The drug is currently in clinical development and is not yet approved.
COL-1077 contains lidocaine, a local anesthetic that works by blocking sodium channels on nerve membranes, thereby preventing the initiation and conduction of nerve impulses. This action numbs the tissue in the area where the gel is applied, reducing pain during endometrial biopsy procedures.
COL-1077 is being developed by Catalent, Inc., a company traded on the New York Stock Exchange under the ticker symbol CTLT. Catalent is a global provider of drug development and delivery solutions, and it is advancing COL-1077 through clinical trials for use in endometrial biopsy.
COL-1077 is in Phase 2 clinical development. It has completed a Phase 2 trial, and it remains an investigational drug that has not received FDA approval. The drug is being evaluated for its safety and efficacy in reducing pain associated with endometrial biopsy procedures.
COL-1077 has been studied in one completed Phase 2 clinical trial, identified as NCT02465320. This trial, titled "COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy," enrolled 187 participants in the United States. The study was randomized, double-blind, and placebo-controlled, and it included women aged 40 years and older.
COL-1077 is a formulation that contains lidocaine as its active ingredient. It is a 10% lidocaine bioadhesive gel specifically designed for use during endometrial biopsy. While lidocaine is a well-known local anesthetic, COL-1077 is a proprietary formulation being developed by Catalent for this specific procedure.