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

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Shionogi

Status and phase

Completed
Phase 2

Conditions

Atrophy
Vaginal Diseases

Treatments

Drug: Ospemifene 15 mg
Drug: Ospemifene 5 mg
Drug: Ospemifene 30 mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00630539
15-50717

Details and patient eligibility

About

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.

Enrollment

126 patients

Sex

Female

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Naturally or surgically menopausal
  • Vaginal pH greater than 5.0
  • 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion criteria

  • Evidence of endometrial hyperplasia, cancer or other pathology
  • Abnormal PAP smear
  • Uterine bleeding of unknown origin or uterine polyps
  • Current vaginal infection requiring medication
  • Use of hormonal medications
  • Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

126 participants in 4 patient groups, including a placebo group

Subjects on placebo
Placebo Comparator group
Description:
Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks
Treatment:
Drug: Placebo
Subjects on ospemifene 5 mg/day
Experimental group
Description:
Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Treatment:
Drug: Ospemifene 5 mg
Subjects on ospemifene 15 mg/day
Experimental group
Description:
Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Treatment:
Drug: Ospemifene 15 mg
Subjects on ospemifene 30 mg/day
Experimental group
Description:
Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Treatment:
Drug: Ospemifene 30 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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