QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena(TM) (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovagin... ( Results presented at 12th World Cong...)

HOME >> MEDICINE >> TECHNOLOGY

QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena(TM) (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovaginal Atrophy

Date:5/21/2008

Results presented at 12th World Congress on the Menopause show significant improvement in vaginal dryness and dyspareunia, two of the most frequent

symptoms associated with vulvovaginal atrophy

ANN ARBOR, Mich., May 21 /PRNewswire/ -- QuatRx Pharmaceuticals today announced further positive data from a pivotal Phase 3 study of Ophena(TM) (ospemifene tablets) to treat postmenopausal women with symptoms of vulvovaginal atrophy, a common condition associated with menopause. In January 2008, QuatRx announced positive top line results for the primary endpoints in the Phase 3 Ophena(TM) clinical trial, in which a statistically significant result in each of four co-primary endpoints was achieved. Results from this additional analysis of secondary endpoints of the Phase 3 study show that women treated with Ophena(TM) experienced improvements in vaginal dryness and dyspareunia (painful intercourse), two of the most frequent symptoms associated with vulvovaginal atrophy. Results of this analysis were presented in an oral presentation today at the 12th World Congress on the Menopause in Madrid, Spain.

The multi-center, double-blind, placebo-controlled study was conducted in 80 U.S. centers and involved 826 postmenopausal women. Fully 90% of women in the study experienced moderate to severe vaginal dryness and 66% experienced moderate to severe dyspareunia. Following 12 weeks of treatment with Ophena(TM), the decrease in the symptom score for patients reporting moderate to severe vaginal dryness was statistically significant as compared to placebo. The symptom score for patients reporting moderate to severe dyspareunia also showed a statistically significant decrease as compared to placebo. Ophena(TM) was generally well tolerated and demonstrated a favorable safety profile.

"For millions of post-menopausal women, the symptoms of vulvovaginal atrophy represent a serious health issue that can have a profound negative impact on quality of
'/>"/>

2

GOOD

Page: 1 2 3
Related medicine technology :

1. QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
2. QuatRx Pharmaceuticals Announces Positive Phase 3 Results for Study of Ophena(TM) (ospemifene) to Treat Postmenopausal Vaginal Syndrome
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
6. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
7. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
8. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
9. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
10. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
11. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac

Post Your Comments:

QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena(TM) (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovagin...( Results presented at 12th World Cong...),Health