Bioequivalence study of Estradiol 10μg tablet and Vagifem® 10μg tablet in healthy postmenopausal women with symptoms of vulvar and vaginal atrophy and no contraindication to estrogen therapy.

Phase 3

• Conditions: Health Condition 1: N952- Postmenopausal atrophic vaginitis

• Registration Number: CTRI/2014/05/004586
• Lead Sponsor: Famy Care Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 465

Inclusion Criteria

•Patient should be able to give written informed consent

•Patients should be Postmenopausal women with vaginal atrophy

•At screening systolic blood pressure be no greater than 150 mm Hg and diastolic blood pressure be no greater than 90 mm Hg

•Patient with no significant illness other than vaginal atrophy as judged by the Investigator

•Ability to comply with requirements of trial

Exclusion Criteria

•Known or suspected allergy to estrogen or any of its excipients

•Known or suspected history of breast carcinoma, Estrogen-dependent neoplasia

•Genital bleeding of unknown cause

•Acute thrombophlebitis or thromboembolic disorder associated with estrogen use

•Known history of drug or alcohol abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified