Approval Probability
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Adjusted LOA
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Imiquimod · 1 trial · 1 indication
HPV clearance will be determined by pathology and HPV testing, followed by colposcopy. Descriptive statistics will include numbers and rates of occurrence with confidence intervals of regression, pre and post-treatment HPV including Human Papillomavirus type 16 (HPV16) and HPV 18/45 typing, and adverse effects. A non-inferiority type design is used in which the difference between treatments is defined as medical treatment being preferable if the regression rate is not more than 10% below that of the excisional treatment. Comparison of the regression rates of the two treatments will be made by a non-inferiority Fisher's exact test.
| Arm | Type | Description |
|---|---|---|
| Loop Electrosurgical Excision Procedure | ACTIVE_COMPARATOR | Excision of the cervical transformation zone by way of the loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC). |
| Imiquimod | EXPERIMENTAL | Imiquimod 12.5mg intravaginally once weekly for 16 weeks |
| Name | Type | Description |
|---|---|---|
| Imiquimod | DRUG | 12.5mg (5%) once a week vaginally for 16 weeks |
| Loop Electrosurgical Excision Procedure | PROCEDURE | Patients with CIN 2-3 will be randomized to receive intervention, CKC or LEEP versus medical therapy with Imiquimod. |
Inclusion Criteria: * Healthy women older than age 21, military or civilian * Negative pregnancy test results * Confirmed CIN 2-3 on cervical biopsy with a negative endocervical curettage (ECC) and satisfactory colposcopy visualizing the complete transformation zone of the cervix. * The patient wil...
Imiquimod is being studied for the treatment of Cervical Intraepithelial Neoplasia, a precancerous condition of the cervix. It is an investigational small molecule in Phase 2 clinical development. The drug is being evaluated as a topical treatment for this condition in women.
Imiquimod is a small molecule immunomodulator. It works by activating immune cells through toll-like receptor 7, which stimulates the body's innate immune response. This mechanism is thought to help the immune system recognize and attack abnormal cervical cells in Cervical Intraepithelial Neoplasia.
Imiquimod is being developed by United Therapeutics Corporation, a publicly traded company listed on NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of Cervical Intraepithelial Neoplasia.
Imiquimod is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of Cervical Intraepithelial Neoplasia, and its safety and efficacy have not yet been established.
Imiquimod has one completed Phase 2 clinical trial with the identifier NCT02130323. This trial, titled 'Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix,' enrolled 22 women aged 21 years and older in the United States. The study was randomized, double-blind, and active-controlled.
Yes, Imiquimod is also known as Aldara. Aldara is a brand name for imiquimod, which is a topical immune response modifier. In the context of this development program, Imiquimod is being studied for the treatment of Cervical Intraepithelial Neoplasia, a different indication from its other uses.