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# Repros Reports Favorable Phase 2 Data for Proellex
- URL: https://www.fdaweb.com/repros-reports-favorable-phase-2-data-for-proellex/
- Published: 2016-04-14T12:00:00.000Z
- Updated: 2026-09-14T20:54:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135373

> Repros Therapeutics says new Phase 2 clinical data show that vaginal administration of Proellex at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, a key symptom of uterine fibroids. “When a sufficient concentration of Proellex is achieved in circulation, amenorrhea (cessation of menses) is achieved,” the company explains. “Just over half, 52%, of Proellex-treated subjects became amenorrheic with no evidence of a dose effect.” Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the drug-treated arms by 18% while the placebo group showed continued increase in size.  
>  
> Repros believes Proellex represents a significant advantage over GnRH agonists and antagonists in treating uterine fibroids. It will soon request an end of Phase 2 meeting with FDA to discuss plans for Phase 3 studies.