Vulvar and vaginal atrophy of postmenopausal women MedDRA version: 9.1 Level: LLT Classification code 10050903 Term: Postmenopausal symptoms
Conditions
Interventions
Product Name: Ospemifene
Pharmaceutical Form: Tablet
INN or Proposed INN: Ospemifene
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Ospemi
Sponsors
Hormos Medical Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject is a woman 40-80 years old at the time of randomization. The subject is postmenopausal. Postmenopausal is defined as - at least 12 months since the last spontaneous menstrual bleeding - hysterectomy with intact ovaries and serum FSH levels > 40 IU/L and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject has taken certain hormonal medications (listed in protocol). Subject has clinically significant abnormal gynecological findings other than vaginal atrophy at screening. Subject has taken a selective estrogen receptor modulator (SERM) or any other medications that are expected to have estrogenic and/or antiestrogenic vaginal effects within 60 days prior to screening. Subject has clinically relevant abnormal findings in any safety laboratory tests. Subject has current history of thromboembolic or blood coagulation disorder. Subject has current history of celebrovascular incident.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy, safety and tolerability of 5, 15, and 30 mg of ospemifene in the treatment of VVA in postmenopausal women. ;Secondary Objective: None. ;Primary end point(s): Percentage of parabasal cells in the MI Percentage of superficial cells in the MI Vaginal pH | — |
Countries
Finland
Outcome results
None listed