Bioequivalence study of Estradiol 10Î¼g tablet and VagifemÂ® 10Î¼g tablet in healthy postmenopausal women with symptoms of vulvar and vaginal atrophy and no contraindication to estrogen therapy.

An assessor blind, parallel, multicentric randomized placebo-controlled study to demonstrate the efficacy and safety of Estradiol 10Î¼g (Test product: Manufactured by Famy Care Ltd., India) with VagifemÂ® (Reference drug: Manufactured by Novo Nordisk Inc., USA) in healthy postmenopausal women with symptoms of vulvar and vaginal atrophy and no contraindication to estrogen therapy. - NA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/05/004586

Enrollment

465

Registered

2014-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N952- Postmenopausal atrophic vaginitis

Interventions

Intervention1: Estradiol- Famy Care: 1 tablet of 10Î¼g once daily to be inserted vaginally for 14 days Control Intervention1: VagifemÂ® - Novo Nordisk: 1 tablet of 10Î¼g once daily to be inserted vag

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Proportion of responders on Day 15 (i.e., one day after the administration of the fourteenth dose of study treatment).Timepoint: 15 days	—

Secondary

Measure	Time frame
Change from baseline in the severity of most bothersome symptomTimepoint: 15 days	—

Countries

India

Contacts

Public ContactRajesh CN

Lambda Therapeutic Research Ltd

praveenshetty@lambda-cro.com917940202098

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026