Clinical Trials Logo
  1. Home
  2. Atrophy
  3. NCT00630539

A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

Atrophy Clinical Trial

Official title:
Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

Clinical Trial Summary

The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00630539
Study type Interventional
Source Shionogi Inc.
Contact
Status Completed
Phase Phase 2
Start date August 2007
Completion date February 2008
View Details
See also
  Status Clinical Trial Phase
Completed NCT02781623 - Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT02497547 - An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy Phase 2
Completed NCT00566982 - A Clinical Study to Evaluate the Safety of Ospemifene Phase 3
Completed NCT01586364 - Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus Phase 3
Active, not recruiting NCT05698316 - A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression
Recruiting NCT05869812 - Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes Phase 2
Completed NCT02770365 - Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy Phase 3
Completed NCT02747641 - Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects N/A
Recruiting NCT02137824 - A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients N/A
Completed NCT01585558 - Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus Phase 3
Completed NCT02868749 - Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue N/A
Recruiting NCT01911312 - Evaluation of Thermal-Aided Muscle Stimulation N/A
Completed NCT00729469 - Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity Phase 3
Completed NCT01553773 - Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment Phase 2
Recruiting NCT02745366 - Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction Phase 1
Completed NCT00807508 - Leucine Supplementation in Elderly Men Phase 1/Phase 2
Completed NCT00744094 - Resistance Training in Elderly Phase 1/Phase 2
Terminated NCT00267839 - Effect of Exercise on Risk-factors of Elderly Women Phase 3
Completed NCT00276094 - A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3