Vulvar and vaginal atrophy of postmenopausal women MedDRA version: 9.1 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy
Conditions
Interventions
Product Name: ospemifene (OphenaTM)
Pharmaceutical Form: Tablet
INN or Proposed INN: ospemifene
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical f
Sponsors
Hormos Medical Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject is a woman 40 to 80 years old at the time of randomization. The subject is postmenopausal. Subject has an intact uterus. The subject has 5% or fewer superficial cells in the maturation index of the vaginal smear The subject has vaginal pH greater than 5.0 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject has double-layer endometrial thickness =4 mm on endometrial ultrasound at screening. Subject has evidence of hyperplasia, cancer or other pathology from the endometrial biopsy at screening. Subject has abnormal Papanicolaou test result at screening. Subject has clinically significant abnormal gynecological findings other than signs of vaginal atrophy. Subject has taken certain hormonal medications (lited in protocol). Subject has taken selective estrogen receptor modulator (SERM) or any other medications that are expected to have clinically significant estrogenic and/or antiestrogenic effects within 60 days prior to screening. Subject has clinically significant abnormal findings at physical examination at screening. Subject is heterozygous or homozygous for Factor V Leiden (test done at screening). Subject has current or history of thromboembolic or blood coagulation disorder. Subject has current or history of cerebrovascular incident.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and long-term safety of ospemifene to support the overall safety profile of ospemifene in the treatment of VVA.;Secondary Objective: None.;Primary end point(s): Change from baseline to Week 12 in the following: • Percentage of parabasal cells in the MI • Percentage of superficial cells in the MI • Vaginal pH | — |
Countries
Belgium, Denmark, Finland, Sweden
Outcome results
None listed