A clinical trial to study the Efficacy and Safety of Estradiol Vaginal Inserts USP 10 mcg of Aurobindo Pharma Ltd, India; Group II (Reference): Vagifem® (estradiol vaginal Inserts) 10 mcg of Novo Nordisk Inc USP 10 mcg in healthy postmenopausal women with symptoms of vulvar and vaginal atrophy
- Conditions
- Health Condition 1: N952- Postmenopausal atrophic vaginitis
- Registration Number
- CTRI/2020/11/029260
- Lead Sponsor
- Aurobindo Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 490
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% superficial cells on vaginal smear cytology at Visit 1 (preliminary screening -7 to -1).
5.Subjects with Vaginal pH > 5.0 at Visits 1 (preliminary screening) & Visit 2 (Day 0 or Day 1).
6.Systolic blood pressure <= 150 mm Hg and diastolic blood pressure <= 90 mm Hg at Visit 1 (preliminary screening -7 to -1).
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 < 4 mm.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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