Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

PHASE3CompletedINTERVENTIONAL
Enrollment

919

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
AtrophyVaginal Diseases
Interventions
DRUG

Ospemifene 60 mg

60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

DRUG

Placebo

oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Hormos Medical

INDUSTRY

collaborator

QuatRx Pharmaceuticals

INDUSTRY

lead

Shionogi

INDUSTRY

NCT00729469 - Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity | Biotech Hunter | Biotech Hunter