A clinical study to evaluate bioequivalence of Estradiol Vaginal Cream (0.01% from Cipla) and Estrace® Estradiol Vaginal Cream (0.01% from Warner Chilcott Inc.) with clinical endpoint in Postmenopausal Females with Vulvar and Vaginal atrophy.

Phase 3

• Conditions: Health Condition 1: null- Vulvar and Vaginal atrophy

• Registration Number: CTRI/2016/09/007231
• Lead Sponsor: Cipla Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-10-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

1.Postmenopausal females aged 40 to 70 years (both inclusive)

2.Patients with Body Mass Index (BMI) >= 19 kg/m2 to <= 38 kg/m2

Postmenopausal females with intact uterus:

- <=5% superficial cells on vaginal smear cytology at screening visit

- 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified