Health Condition 1: N952- Postmenopausal atrophic vaginitis
Conditions
Interventions
Intervention1: Estradiol Vaginal Inserts USP 10 mcg: Dose: 10 mcg
Route: Vaginal Insertion
Frequency: Once daily for 14 Days
Control Intervention1: Vagifem® (Estradiol vaginal Inserts) 10 mcg: Dose
Sponsors
Aurobindo Pharma Limited
AXIS Clinicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy postmenopausal female subjects aged 40 to 75 years, both inclusive. [NOTE: Postmenopausal is defined as having had 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.] 2. Subjects should be willing and able to understand and provide written informed consent for the study. 3. At least 1 subject self-assessed moderate to severe symptom of VVA among the following 4 symptoms that was identified by the subject as being most bothersome to her: • Vaginal dryness • Vaginal and/or vulvar irritation/itching • Dysuria • Vaginal pain associated with sexual activity • The presence of vaginal bleeding associated with sexual activity 4. Subjects with 5. Subjects with Vaginal pH > 5.0 at Visits 1 (preliminary screening) & Visit 2 (Day 0 or Day 1). 6. Systolic blood pressure 7. Subjects should show a Normal clinical breast examination at Visit 1. 8. For women with intact uterus, vaginal ultrasonography at Visit 1 should confirm an inactive endometrial lining, with an endometrial thickness 9. Subjects should be in general good health, with no clinically significant disease (other than symptoms of VVA) that could interfere with the study evaluations. 10. Subjects should be able to understand and comply with the requirements of the study, including applying the medication as instructed, returning for the required study visits, complying with therapy prohibitions for the complete duration of the study.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to estradiol vaginal insert or any component of the study medication. 2. A subject who had received any treatment listed below more recently than the indicated washout period prior to Visit 1/Screening/Baseline. • Vaginal lubricants or moisturizers - (at least 48 hours (2 days) • Vaginal hormonal products (rings, creams, gels) - (at least 1 week (7 days) • Transdermal estrogen alone or estrogen/progestin products - (at least 4 weeks (28 days) • Oral estrogen and/or progestin therapy - (at least 8 weeks (56 days) • Intrauterine progestin therapy - (at least 8 weeks (56 days) • Progestin implants and estrogen alone injectable drug therapy - (at least 3 months (90 days) • Estrogen pellet therapy or progestin injectable drug therapy - (at least 6 months (180 days) 3. Clinical breast examination results indicating any suspicion of breast malignancy. 4. Known, suspected, or history of breast cancer or cervical cancer or any estrogen-dependent neoplasia. 5. History of undiagnosed genital bleeding. 6. Known bleeding disorder. 7. History of significant risk factors for endometrial cancer for women with intact uterus (i.e., tamoxifen use, prior pelvic radiation therapy, and endometrial hyperplasia). 8. Hysterectomy without oophorectomy unless 60 years or older. 9. Subjects with low Haemoglobin levels as per PIâ??s discretion. 10. Active deep vein thrombosis, pulmonary embolism, or history of these conditions. 11. Active arterial thromboembolic disease (e.g., stroke or myocardial infarction) or a history of these conditions. 12. Active Liver dysfunction or disease or history of Cholestatic Jaundice 13. Known protein C, protein S, antithrombin deficient, or other known thrombophilic disorders. - Active vaginal herpes simplex infection or any known, untreated vaginal infections. 14. Any clinically significant condition that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. 15. Use of any investigational drugs or device within 30 days prior to screening 16. Known anaphylactic reaction or angioedema to Estradiol or any Estradiol containing medication 17. Subjects with any absolute or relative contraindications to estrogen therapy as per PIâ??s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A responder is defined as a subject with at least a 25 percent reduction from baseline in the sum of percent basal or parabasal plus percentage intermediate cells on vaginal cytology AND vaginal pH less than 5.0 with a change from baseline vaginal pH of at least 0.5Timepoint: The proportion of subjects in the Per Protocol (PP) population that are identified as responders on Day 15 between the three groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to EOS in the severity of Most Bothersome Symptom of vulvar and vaginal atrophy (VVA).Vulvar and vaginal atrophy (VVA) will be self-assessed by the subject at baseline and visit 4Timepoint: 14 days | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Ltd
Outcome results
None listed