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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 developed by Catalent, Inc. (ticker CTLT). It is a lidocaine bioadhesive gel at a 10% concentration, formulated for local application. It has been studied in women undergoing transvaginal Pipelle-directed endometrial biopsy, a procedure used to sample the uterine lining.
COL-1077 was studied for use in women undergoing transvaginal Pipelle-directed endometrial biopsy. The Phase 2 trial enrolled women aged 40 years and older in the United States. The goal was to evaluate the gel in the setting of this office-based uterine sampling procedure.
COL-1077 is developed by Catalent, Inc., which trades under the ticker CTLT. Catalent is the sponsor associated with the clinical program for this lidocaine bioadhesive gel. No other developer or partner is identified for the asset.
COL-1077 has completed a Phase 2 clinical trial. It is an investigational product and is not described as approved by the FDA. The single registered study, NCT02465320, is listed as completed, and no active trials are currently recorded for the program.
COL-1077 has been evaluated in one clinical trial, NCT02465320, titled COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy. The Phase 2 study was randomized, double-blind, and placebo-controlled, enrolling 187 participants in the United States. It is listed as completed.
COL-1077 is a lidocaine bioadhesive gel at 10% concentration, so the trial title refers to the same product. Searches for the lidocaine bioadhesive gel used in endometrial biopsy point to COL-1077, the Catalent (CTLT) investigational asset studied under NCT02465320.