Health Condition 1: null- Vulvar and Vaginal atrophy
Conditions
Interventions
Intervention1: Estradiol vaginal cream (0.01%): Cipla Ltd.
Dose: 2 gm
Frequency: once daily
Duration: 7 days
Route of Administration: Vaginal
Control Intervention1: Estrace® Estradiol Vaginal Cre
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Postmenopausal females aged 40 to 70 years (both inclusive) 2.Patients with Body Mass Index (BMI) >= 19 kg/m2 to Postmenopausal females with intact uterus: - - Vaginal pH > 5.0 at screening visit - At least one, patient self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy (VVA) from the following list that is identified by the patient as being most bothersome to her: •Vaginal dryness •Vaginal and/or vulvar irritation/itching •Dysuria •Vaginal pain associated with sexual activity OR •Vaginal bleeding associated with sexual activity 3. Patients willing to voluntarily provide written informed consent. 4. Patient willing to be adhere to protocol and study requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with known, suspected, or history of breast cancer or cervical cancer or any other known or suspected estrogen dependant neoplasia 2. Known hypersensitivity to estradiol vaginal cream or any component of the study medication. 3. Patients with undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer 4. Patients with active vaginal herpes simplex infection or any known concurrent vaginal infections 5. Patients on medication indicated for anticoagulation which includes but is not limited to warfarin, heparin, NSAIDs, clopidogrel, dabigatran, etc. 6. Patient who had engaged in sexual intercourse within 48 hours (2 days) of screening. 7. Patient with contraindication to estrogen therapy 8. Any other systemic disease, malignancy or any other abnormal laboratory values which as per investigator will interfere with patients participation in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in the per protocol (PP) population that are identified as responders at the end of treatment period and proportion of patients with Vaginal pH 5.0 at Day 8, with change from baseline vaginal pH of at least 0.5 in all treatment groups. Timepoint: 8 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients that achieves treatment success at the end of the treatment period (day 8) from baseline in most bothersome symptoms of vulvar and vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity) between treatment groups. Timepoint: 8 days | — |
Countries
India
Contacts
Public ContactMonica Razdan
Cipla Ltd.
Outcome results
None listed