Health Condition 1: N768- Other specified inflammation of vagina and vulva Health Condition 2: null- Vulvar and Vaginal Atrophy
Conditions
Interventions
Intervention1: Estradiol vaginal tablet, 10mcg estradiol (Sun Pharmaceutical Industries Ltd.
India): Tablets are to be inserted once daily for 14 days. Treatment is started on Day 0. Tablet
is gently
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: (this particular trial does not have any specific age range and is meant for post menopausal women) 1. Postmenopausal woman (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weekspostsurgical bilateral oophorectomy with or without hysterectomy) 2. At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy (VVA) from the list in Section 7.1. 3. 4. Vaginal pH > 5.0 5. In women with an intact uterus, inactive endometrial lining and endometrial thickness 6. Women >40 years having documentation of a negative screening mammogram (obtained at screening or within 9 months of study enrollment) 7. Normal clinical breast examination
Exclusion criteria
Exclusion criteria: 1. Taking estrogen alone or estrogen/progestin containing drug products. (Washout periods recommended before baseline assessments for subjects previously on estrogen alone or estrogen/progestin containing products as in Section 6.2.2) 2. Known or suspected allergy to estradiol or related products 3. Known, suspected or past history of breast cancer 4. Abnormal genital bleeding 5. History of significant risk factors for endometrial cancer 6. Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration 7. Known insulin dependent or non-insulin dependent diabetes mellitus 8. Systolic blood pressure (BP) of more than 150 mm Hg and/or diastolic BP or more than 90 mm Hg, currently treated or untreated 9. Active deep venous thrombosis or thromboembolic disorders or a history of these conditions 10. Active arterial thrombosis or a documented history of this condition 11. Known or suspected liver and/or kidney impairment based on medical history, physical examination 12. Known or suspected vaginal infection requiring further treatment 13. Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day) 14. Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal pH, Vaginal cytologyTimepoint: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms of vulvar and vaginal atrophy (VVA)Timepoint: Day 14 | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed