Repros to Revise Trial Endpoints for Androxal
Posted on: Wednesday, 17 October 2007, 15:00 CDT
Repros Therapeutics plans to submit a revised trial protocol to the FDA for its secondary hypogonadism treatment Androxal after a meeting with the agency.
During the meeting with the FDA, male sexuality was mutually determined not to be appropriate as a clinical endpoint. As a result of the meeting, Repros plans to submit a new revised protocol focusing on endocrinological outcomes to the FDA.
Post study analysis of the population studied in a recently completed Androxal trial was consistent with men who had adult-onset idiopathic hypogonadotropic hypogonadism (AIHH). Men with AIHH are characterized as having both low testosterone and luteinizing hormone often accompanied by obesity and elevated blood glucose, among other signs. A retrospective analysis of results from this trial suggests that Androxal modifies the endocrinologic profile in terms of both hormones and glucose.
Joseph Podolski, president and CEO of Repros, stated: "I am encouraged by the openness of the discussions with the FDA regarding the possibilities of our future clinical development for Androxal. We believe Androxal may have the potential to reach a broader spectrum of endocrinological dysfunctions beyond the effects of low testosterone alone."
Source: Datamonitor
Related Articles
- AspenBio Pharma Reports on FDA 510(K) Clinical Trial Progress for AppyScore, World's First Blood-Based Diagnostic Test for Human Appendicitis
- Guided Therapeutics, Inc. Announces Completion of Subject Enrollment of FDA Pivotal Clinical Trial
- Patient Enrollment for AspenBio Pharma's FDA 510(K) Clinical Trial for AppyScore(TM), World's First Appendicitis Blood Test, Nearing Halfway Point
- Vion Pharmaceuticals: FDA Allows Leukemia Trial to Resume
- AVANIR Pharmaceuticals Summarizes Outcome of FDA Meeting on Zenvia NDA
- AVANIR Pharmaceuticals Announces Conference Call to Provide Zenvia FDA Meeting Update
- Horizon Therapeutics Announces Special Protocol Assessment With FDA for Phase 3 Trial Program
- Following FDA Meeting BDSI Projects Submission of BEMA(TM) Fentanyl NDA In Second Quarter 2007
- SpectRx, Inc. Granted Key Patent for Non-Invasive Cervical Cancer Detection Technology; Guided Therapeutics Device in FDA Pivotal Clinical Trial
- FDA Requests Confirmatory Trial for Approval of PMA for OrCel in the Treatment of Venous Ulcers
 |
 |
User Comments (0)
RSS Feeds