atrophic vaginitis MedDRA version: 8.1 Level: LLT Classification code 10003690 Term: Atrophic vaginitis
Conditions
Interventions
Product Name: Vagifem Low Dose
Pharmaceutical Form: Vaginal tablet
INN or Proposed INN: estradiol, as estradiol hemihydrate
Current Sponsor code: NN4001
Concentration unit: µg microgram(s)
Concentrati
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent to be obtained before any trial related activities. (Trial related activities are any procedure that would not have been performed during normal management of the subject.) 2.Postmenopausal women aged 45 years or older at the time of screening. 3.Postmenopausal women = 2 years after last menstruation; or bilateral oophorectomy performed 2 years or more prior to the time of screening. 4.Serum FSH levels > 40 mIU/ml and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Known or suspected allergy to trial product or related products. 2.Known, suspected or past history of breast cancer. 3.Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer. 4.Endometrial hyperplasia or endometrial polyps diagnosed during the screening period. 5.Abnormal genital bleeding of unknown etiology. 6.Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months prior to the screening visit 7.Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-estrogenic medications including K-Y jelly etc., 1 month prior to Visit 2. 8.Hot flushes which require systemic HT treatment. 9.Known insulin dependent or non-insulin dependent diabetes mellitus. 10.Systolic blood pressure (BP) = 160 mm Hg and/or diastolic BP = 100 mm Hg, currently treated or untreated. 11.Active deep venous thrombosis or thromboembolic disorders or a history of these conditions. 12.Active arterial thrombosis or a documented history of this condition. 13.Known or suspected hepatic and/or renal impairment based on medical history, physical examination, and/or laboratory results. 14.Porphyria. 15.Body Mass Index (BMI)> 35.0 kg/m2. 16.Papanicolaou cervical smear presenting PAP class > II. 17.Known or suspected vaginal infection requiring further treatment. 18.Uterovaginal prolapse Grade II-IV POPQ (pelvic organ prolapse qualification scale). 19.Hysterectomy or endometrial ablation 20.Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day). 21.Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine. 22.Previous participation in this trial. 23.Subject who has participated in any other trial involving other investigational products within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the endometrial hyperplasia rate from endometrial biopsies taken at the beginning and at the end of study treatment (12 months). ;Secondary Objective: ;Primary end point(s): The primary safety endpoint is the hyperplasia rate at the end of study (12 months). | — |
Countries
Czech Republic, Denmark, Finland, France, Hungary, Sweden
Outcome results
None listed