Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women

• Status: Completed
• Trial end date: 2003-06-06
• Target enrollment: 0
• Participant gender: Female

Summary

This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Hormones; Norethindrone; Norethindrone Acetate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Healthy women

• At least 3 months on Trisekvens® before screening period

• Ability to understand and comply with the protocol requirements

Exclusion Criteria:

• Less than 12 months or more than 36 months postmenopausal judged by the Investigator

• Known, suspected, or past history of hormone dependent tumor/cancers

• Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions

• Ischemic heart disease or myocardial infarction within 6 months prior to randomization