check_circleStudy Completed

Therapeutic Equivalency, Postmenopause, Hormone Replacement Therapy

Study to demonstrate bioequivalence after single oral administration of the two different Estradiol Valerate-containing preparations in postmenopausal women

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal
36
Trial Dates
July 2002 - September 2002
Phase
Phase 1
Could I Receive a placebo
N/A
Products
Estradiol Valerate (EV, DS00124)
Accepts Healthy Volunteer
N/A

Primary Outcome

Secondary Outcome

Trial design

Open-label, randomized, two-way crossover study to demonstrate bioequivalence after single oral administration of the two different estradiol valerate-containing preparations Estradiol 2 mg Jenapharm and Merimono 2 mg in 36 healthy postmenopausal women
Trial Type
Interventional
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A