Plethora Completes Patient Recruitment in Phase IIb Dysmenorrhoea Study
Posted on: Friday, 25 April 2008, 09:01 CDT
Plethora Solutions has completed patient recruitment in a Phase IIb study in dysmenorrhoea, which is a painful and often incapacitating menstrual cramp that afflicts over 50% of women of reproductive age and is one of the leading causes of absenteeism from work and school.
The study was designed to confirm an earlier proof of concept study. It is a 'gold standard' double-blind, placebo-controlled, multiple-dose crossover study comparing the efficacy of intra-vaginally delivered PSD508 to that of oral non-steroidal anti-inflammatory drugs (NSAID) and placebo in relieving menstrual-associated pain.
This study is taking place across three consecutive menstrual cycles, allowing the trial to be completed in the shortest possible time frame. The study will also add to the extensive existing clinical data on the safety and tolerability of PSD508. A total of 159 patients have been enrolled into the study at three centres in the UK.
PSD508 is a proprietary delivery form of a well characterised NSAID, which is administered intra-vaginally utilising technology which Plethora licensed from Metris Therapeutics in 2006. This novel approach has the potential benefit of allowing women to access a convenient 'on-demand' treatment containing an NSAID while minimising systemic exposure to the drug and thereby lowering the risk of side effects which limit the usefulness of existing therapies.
Mike Wyllie, chief scientific oficer of Plethora, said: "The conclusion of this study, when the outcome is reported in full later this year, will also end our period of significant investment in Phase II studies in our women's health portfolio. These include PSD503 for the treatment of stress urinary incontinence, PSD506 for overactive bladder and PSD597 for the treatment of interstitial cystitis; all of which are now the subject of early stage licensing discussions."
Source: Datamonitor
Related Articles
- Study Finds More Effective Treatment for Pneumonia Following Influenza
- First Ever Study on Alzheimer's Disease Treatment in Hispanics Presented at Major Medical Meeting
- Intent-to-Treat Analysis of Double-Blind Methamphetamine Study Confirms Hythiam's PROMETA Treatment Program Showed Statistically Significant Reduction in Cravings Compared to Placebo
- QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women With Postmenopausal Vaginal Syndrome
- Study Picks Older Psoriasis Treatment
- New Studies Identify Advances in Treatment Of Chronic Myeloid Leukemia
- Treat Fast, Get Results -- Two Studies of Poor, Low-Income Women Show Gains After Tests for Cervical Cancer
- Study: Genes Play Role in Women's Orgasms
- Study: Aspirin Prevents Strokes in Women
- Doctors Study Viagra As Stroke Treatment
 |
 |
User Comments (0)
RSS Feeds