Efficacy and Safety of SPILs Estradiol vaginal tablet, in subjects with Vulvar and Vaginal Atrophy
- Conditions
- Health Condition 1: N768- Other specified inflammation of vagina and vulvaHealth Condition 2: null- Vulvar and Vaginal Atrophy
- Registration Number
- CTRI/2012/09/002983
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 405
(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. <= 5% superficial cells on vaginal smear cytology
4. Vaginal pH > 5.0
5. In women with an intact uterus, inactive endometrial lining and endometrial thickness
<4 mm as documented on vaginal ultrasonography
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method